N/A 97725 (UDI 00613994925961)Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00613994925961), received between Nov 17, 2017 and Feb 19, 2020 — classified as 27 injuries, 30 malfunctions.

The most frequently reported specific device problem is “High impedance” (19 reports).

9 other recalls cover devices cleared under the same FDA submission (P840001); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2020High impedance; Device Damaged Prior to Receipt by User; High impedance; Device Damaged Prior to Receipt by User

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THE REP COULDN'T ENTER THE FACILITY TO RETRIEVE THE DEVICE DUE TO COVID-19 AND THEY DIDN'T KNOW IF THE FACILITY STILL HAD THE REMOVED DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9728894 ↗
• MalfunctionAug 19, 2019Failure to Deliver Energy; Migration or Expulsion of Device; Malposition of Device; Charging Problem; Failure to Deliver Energy; Migration or Expulsion of Device; Malposition of Device; Charging Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WITH AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATION. IT WAS REPORTED THAT PATIENT HAD THE TRIAL PLACED ON (B)(6) 2019 AND HAD A COUPLE OF REALLY GOOD DAYS WITH IT UNTIL IT SUDDENLY STOPPED. THE CONTROLLER SHOWED NO DEVICE FOUND. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER (HCP). THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING (I.E. RESETTING CONTROLLER, MOVING AWAY FROM ANY EMI SOURCES, ENSURING TOP OF CONTROLLER WAS NOT COVERED, PATIENT CONFIRMING CABLES ARE STILL ATTACHED, ETC.). NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) 2019-07-30. IT WAS REPORTED THAT TROUBLESHOOTING INCLUDED TAKING OUT LEAD AND PLUGGING BACK INTO THE WENS. IT WAS NOT DISCONNECTED BUT THE REP WANTED TO ENSURE IT WAS IN THE CORRECT POSITION. THE TRIAL ENDED AFTER 3 DAYS. THE HEALTHCARE PROVIDER (HCP) BELIEVED THE LEAD CAME OUT OF THE EPIDURAL SPACE BECAUSE IT WASN¿T AS HIGH AS THE HCP WOULD HAVE LIKED DUE TO THE PATIENT¿S ANATOMY. IT WAS NOT A DEVICE ISSUE; THE LEAD CAME FREE FROM THE EPIDURAL SPACE. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Inadequate Pain Relief; Therapeutic Response, Decreased

  MAUDE report 8907681 ↗
• InjuryAug 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE, REGARDING A TRIAL PATIENT. IT WAS REPORTED THAT DURING THE TRIAL, THE PATIENT COMPLAINED OF LEFT BURNING LEG PAIN DURING THE PROCEDURE AND OVERALL INCREASED PAIN IN HER BACK AND LEGS. IT ALL PROGRESSIVELY INCREASED INTO THE NIGHT AND WAS WORSE THE NEXT DAY. PATIENT ALSO EXPERIENCED VOMITING, DIARRHEA, TEMPORARY PARALYSIS (IN HER LEGS) AND RASHES. THE CAUSE WAS UNKNOWN. DURING THE TRIAL IMPLANTING PROCEDURE, MULTIPLE LATERAL AND A-P X-RAYS WERE DONE IN ORDER TO ASSESS PROPER LEAD PLACEMENT. X-RAYS WERE ALSO DONE ON (B)(6) 2019 IN ORDER TO ASSESS LEAD MIGRATION. MEDICATIONS WERE GIVEN AND THE LEADS WERE PULLED ON (B)(6) 2019. THE ISSUE WAS RESOLVED. PATIENT STATES THAT BOTH THE DOCTOR AND MANUFACTURER SHOULD HAVE KNOWN THAT SHE WOULD REACT THE WAY THAT SHE DID, WHICH IS COMPLETELY OUT OF THE BALL PARK OF REASONABILITY. PATIENT ALSO SAID THAT SHE WOULD DO ANOTHER TRIAL IF MEANT THAT SHE WOULD DO WELL. THE HCP WILL NOT ENTERTAIN THAT THOUGHT. PATIENT'S WEIGHT WAS ASKED BUT UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ON (B)(6) 2019 ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. RE

  Patient problems: Burning Sensation; Diarrhea; Pain; Paraplegia; Rash; Vomiting

  MAUDE report 8890378 ↗
• InjuryJul 2, 2019Failure to Deliver Energy; High impedance; Failure to Deliver Energy; High impedance

  ADDITIONAL INFORMATION WAS REPORTED THAT THE CAUSE OF THE PATIENT'S HIGH IMPEDANCES WAS NOT DETERMINED. THE PATIENT'S HIGH IMPEDANCE DID COME DOWN OVER TIME AND AS OF TODAY THE PATIENT HAS STIMULATION. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information; Therapeutic Effects, Unexpected

  MAUDE report 8755944 ↗
• InjuryJun 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2019, MPXR 638055 (CON, REP): INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE, REGARDING A TRIAL PATIENT. IT WAS REPORTED THAT PATIENT WENT TO THE ER COMPLAINING OF PAIN AT THE PROCEDURE SITE.

  Patient problems: Cellulitis; Fever; Pain

  MAUDE report 8734458 ↗
• InjuryJun 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT WITH A WIRELESS EXTERNAL NEUROSTIMULATOR (WENS). IT WAS REPORTED THAT THE PATIENT STARTED THE TRIAL LAST WEEK ((B)(6)) AND CAME IN FOR A LEAD PULL AND HAD CLEAR DRAINAGE. THE REP SPECULATED THE PATIENT MUST HAVE HAD A WET TAP DURING THE TRIAL. THE REP STATED THAT THE PATIENT CAME INTO OFFICE FOR A BLOOD PATCH BUT WAS THEY WERE RUNNING A FEVER SO IT WASN'T DONE. THE REP SAID THE PATIENT ALSO REPORTED LOW BACK PAIN (BELOW TRIAL INCISION SITE). THE HEALTHCARE PROFESSIONAL (HCP) STARTED THE PATIENT ON ANTIBIOTICS AND WAS SENT FOR MRI WITH AND WITHOUT CONTRAST. THE REP SAID THEY ASKED THE HCP TO GIVE THEM AN UPDATE WHEN THEY HAVE MORE INFORMATION. NO DEVICE ISSUES WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Cerebrospinal Fluid Leakage; Fever; Pain; Unspecified Infection

  MAUDE report 8676511 ↗
• InjuryMay 24, 2019High impedance; High impedance

  INFORMATION WAS RECEIVED FROM AN HEALTHCARE PROFESSIONAL (HCP), VIA MANUFACTURER REPRESENTATIVE (REP), REGARDING AN SCS TRIAL PATIENT. IT WAS REPORTED THAT INTRA-OP, HIGH IMPEDANCES WERE NOTED ON ALL CONTACTS. THE REP BELIEVED THAT THE HIGH IMPEDANCES WERE DUE TO A WET TAP. THEY CHANGED THE NEEDLE AND LEAD AND THE HIGH IMPEDANCES STILL REMAINED. THE HCP PERFORMED A BLOOD PATCH AND THEY LEFT THE SCS OFF. THE PRODUCTS WERE REPLACED AND THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP WHO REPORTED THE PATIENT WAS DOING WELL. LATER, IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES ON ALL CONTACTS. THE REP BELIEVED THE CAUSE OF THE ISSUE WAS THE WET TAP. THE REP CHANGED THE LEAD, NEEDLE, AND WENS. A BLOOD PATCH WAS DONE AND THE REP WENT TO A DIFFERENT LEVEL. THE ISSUE WAS RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 8641973 ↗
• MalfunctionApr 26, 2019High impedance; Device Damaged Prior to Receipt by User; Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information; High impedance; Device Damaged Prior to Receipt by User; Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT WITH A WIRELESS EXTERNAL NEUROSTIMULATOR (WENS). IT WAS REPORTED THAT HALF OF THE IMPEDANCES WERE SHOWING AS RED. THE MANUFACTURER REPRESENTATIVE STATED THAT NO MATTER WHAT THEY DID, THE IMPEDANCES WOULD STILL SHOW AS RED. THE LEAD WAS FLIPPED FROM 0-7 AND 8-15 BUT THEY GOT THE SAME RESULTS. IT WAS REPORTED THAT IMPEDANCE VALUES WERE GREATER THAN 40,000 OHMS. THE MANUFACTURER REPRESENTATIVE CLARIFIED THAT ONLY FOUR ELECTRODES WERE RED. WHEN USING CONTACTS 0-7, CONTACTS 4-7 WERE RED. IT WAS NOTED THAT THE WENS AND LEAD WERE REPLACED WITH NO CHANGE IN RESULTS. THE PATIENT¿S HEALTHCARE PROVIDER (HCP) PULLED THE LEAD BACK AND ALL OF THE IMPEDANCES WERE GREEN. HOWEVER, WHEN PLACING THE LEAD IN THE PROPER POSITION, THEY WOULD ALL GO RED AGAIN. IT WAS CONFIRMED THAT SALINE WAS NOT USED. IT WAS FURTHER REPORTED ON (B)(4) 2019 THAT THE MANUFACTURER REPRESENTATIVE COULD ONLY GET TO 0.6 MILLIAMPS (MA) ON THE LEAD THAT HAD THE HIGH IMPEDANCES AND AN OUT OF REGULATION (OOR) ERROR MESSAGE WAS DISPLAYED ON THE TABLET. THE MANUFACTURER REPRESENTATIVE ENDED UP PROGRAMMING THE OTHER LEAD THAT HAD THE NORMAL IMPEDAN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8557812 ↗
• MalfunctionApr 17, 2019Break; Device Damaged Prior to Receipt by User; Connection Problem; Break; Device Damaged Prior to Receipt by User; Connection Problem

  ADDITIONAL INFORMATION WAS REPORTED THAT BOTH LEADS HAD BAD CONTACTS. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8524806 ↗
• InjuryApr 15, 2019Therapy Delivered to Incorrect Body Area; Malposition of Device; Therapy Delivered to Incorrect Body Area; Malposition of Device

  INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE AND A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO TRIALING A WIRELESS EXTERNAL NEUROSTIMULATOR (WENS). IT WAS REPORTED THAT INTRA-OP THE PATIENT'S IMPEDANCES WERE WITHIN THE NORMAL LIMIT. THE PATIENT REPORTED STIMULATION BEING IN THEIR ABDOMEN AND AN X-RAY CONFIRMED THE LEAD WAS IN AN ANTERIOR POSITION; THE PHYSICIAN REPOSITIONED THE LEADS AND THE PATIENT THEN HAD STIMULATION IN THEIR LEFT LEG AND RIGHT LEG. UPON DISCHARGE, THE PATIENT WAS UNABLE TO STAND AND AN MRI SHOWED A BLOOD CLOT OCCURRED IN THEIR SPINE. AN EMERGENCY SURGERY WAS PERFORMED- THE LEAD WAS REMOVED AND THEN THE BLOOD CLOT WAS REMOVED. THE ISSUE WAS RESOLVED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Thrombosis; Undesired Nerve Stimulation

  MAUDE report 8513796 ↗
• MalfunctionMar 12, 2019High impedance; Low impedance; Impedance Problem; High impedance; Low impedance; Impedance Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT USING A WIRELESS EXTERNAL NEUROSTIMULATOR (WENS). IT WAS REPORTED THAT ON MARCH 1, 2019, THE REP WAS IN A TRIAL IMPLANT PROCEDURE. THEY WERE GETTING MULTIPLE CONTACTS SHOWING OPEN CIRCUITS AND LOW IMPEDANCES. THEY THOUGHT IT WAS DUE TO THE WENS, SO THEY REPLACED THE WENS BUT THE ISSUE PERSISTED. THEN, THEY DECIDED TO REPLACE ONE LEAD. WITH THE NEW LEAD, THEY IDENTIFIED AN OPEN CIRCUIT. THE LEAD WAS EXAMINED AND NO DAMAGE TO THE LEAD WAS IDENTIFIED. TECHNICAL SERVICES REVIEWED DIFFERENT OPTIONS FOR THEM TO TRY. AT THE END OF THE TROUBLESHOOTING CALL, ONE SIDE HAD ONE CONTACT THAT WAS "OUT" AND THE OTHER SIDE HAD TWO CONTACTS THAT WERE "OUT". THE HCP CLEANED THE INS END OF THE LEAD WITH A WET LAP TO SEE IF DRIED BLOOD WAS AT THE END OF THE LEAD THAT WAS CAUSING THE IMPEDANCE ISSUES. THE LEADS WERE TESTED AGAIN WITH THE REPLACEMENT WENS AND NO IMPEDANCES WERE FOUND. AT THE END OF THE TRIAL, BOTH WENS WERE DISCARDED BY THE CUSTOMER. THE INITIAL LEAD WAS KEPT AND WILL BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS W

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8413533 ↗
• MalfunctionMar 12, 2019High impedance; Low impedance; High impedance; Low impedance

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT USING A WIRELESS EXTERNAL NEUROSTIMULATOR (WENS). IT WAS REPORTED THAT ON (B)(6) 2019, THE REP WAS IN A TRIAL IMPLANT PROCEDURE. THEY WERE GETTING MULTIPLE CONTACTS SHOWING OPEN CIRCUITS AND LOW IMPEDANCES. THEY THOUGHT IT WAS DUE TO THE WENS, SO THEY REPLACED THE WENS BUT THE ISSUE PERSISTED. THEN, THEY DECIDED TO REPLACE ONE LEAD. WITH THE NEW LEAD, THEY IDENTIFIED AN OPEN CIRCUIT. THE LEAD WAS EXAMINED AND NO DAMAGE TO THE LEAD WAS IDENTIFIED. TECHNICAL SERVICES REVIEWED DIFFERENT OPTIONS FOR THEM TO TRY. AT THE END OF THE TROUBLESHOOTING CALL, ONE SIDE HAD ONE CONTACT THAT WAS "OUT" AND THE OTHER SIDE HAD TWO CONTACTS THAT WERE "OUT". THE HCP CLEANED THE INS END OF THE LEAD WITH A WET LAP TO SEE IF DRIED BLOOD WAS AT THE END OF THE LEAD THAT WAS CAUSING THE IMPEDANCE ISSUES. THE LEADS WERE TESTED AGAIN WITH THE REPLACEMENT WENS AND NO IMPEDANCES WERE FOUND. AT THE END OF THE TRIAL, BOTH WENS WERE DISCARDED BY THE CUSTOMER. THE INITIAL LEAD WAS KEPT AND WILL BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WER

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8413487 ↗
• InjuryFeb 5, 2019Break; High impedance; Inappropriate/Inadequate Shock/Stimulation; Break; High impedance; Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS TRAILING A SPINAL CORD STIMULATION SYSTEM. IT WAS REPORTED THAT THERE WAS A BURIED LEAD TRIAL IN PROGRESS. THE NEUROSURGEON INSERTED THE PADDLE INTO THE EPIDURAL SPACE AND CONNECTED THE EXTENSION FOR THE PURPOSE OF THE PADDLE TRIAL. THE SURGICAL TECHNICIAN SHOUTED THAT SHE WAS SHOCKED AS SHE WAS TRYING TO SEAT THE LEADS INTO THE WIRELESS EXTERNAL NEUROSTIMULATOR. THE SURGICAL TECHNICIAN WAS TRYING TO USE THE EXTENSION SCREW DRIVER TO TRY AND SEAT THE LEAD INTO THE CONTACTS. THE MANUFACTURER REPRESENTATIVE CHECKED IMPEDANCES AND THE ENTIRE ROW OF ELECTRODES 0-7 WERE OUT WITH IMPEDANCES GREATER THAN 40,000 OHMS. THE PATIENT¿S WIRELESS EXTERNAL NEUROSTIMULATOR WAS REPLACED POST OPERATION TO SEE IF THAT FIXED THE PROBLEM. IT DID NOT. IT COULD BE THAT THE EXTENSIONS AND THE LEADS ARE NOT SEATED PROPERLY OR THE ELECTRICAL SHOCK THAT THE SURGICAL TECHNICIAN EXPERIENCED CAUSED A SHORTAGE. THE CAUSE OF WHY THE ENTIRE ROW ON THE PADDLE IS NOT FUNCTIONING IS UNKNOWN. THE PATIENT IS CURRENTLY IN PROGRESS OF THE TRIAL AND RECEIVING STIMULATION FROM ONE SIDE OF THE PADDLE. THE PATIENT WAS SENT HOME WITH THE S

  Patient problems: Headache, Lumbar Puncture; No Known Impact Or Consequence To Patient; Pain; Perforation

  MAUDE report 8307761 ↗
• InjuryJan 10, 2019High impedance; Therapeutic or Diagnostic Output Failure; High impedance; Therapeutic or Diagnostic Output Failure

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH A WIRELESS EXTERNAL NEUROSTIMULATOR (WENS). IT WAS REPORTED THAT THE REP AND HEALTHCARE PROFESSIONAL (HCP) DID A PADDLE LEAD TRIAL WITH EXTENSIONS AND TUNNELED TO THE SIDE. THE REP STATED THEY WERE IN POST-OP AND EVERY CONTACT IS "OUT" EXCEPT FOR THE TOP TWO. THE REP INITIALLY REPORTED THAT IMPEDANCES WERE 4000 OHMS AND RED X'S BUT LATER CLARIFIED THAT THEY WERE ALL 40K OHMS. THE REP STATED THEY TESTED THE LEAD ONLY IN THE OR AND THE PATIENT FELT STIMULATION AND A FULL ELECTRODE IMPEDANCE CHECK SHOWED EVERYTHING WAS FINE. THE REP SAID THEY TESTED THE LEAD/EXTENSION CONNECTION AND EVERYTHING WAS FINE, EVEN AFTER TIGHTENING CONNECTION FURTHER AND TESTING AGAIN. THE REP SAID THEY REINSERTED THE EXTENSION INTO THE WENS MULTIPLE TIMES AND THE OUT OF RANGE IMPEDANCES WERE CONSISTENT EVERY TIME THEY RECONNECTED TO THE WENS. THE REP CHECKED REFERENCE ELECTRODE 1 WHICH THEN SHOWED EVERYTHING WAS OVER 40K. THE REP STATED THEY ATTEMPTED TO INCREASE THE AMPLITUDE A ND THE SYSTEM IMMEDIATELY GOES INTO OOR AT 0.1 MA (ON BOTH THE TABLET AND THE CONTROLLER). THE REP LATER REPORTED THAT THE PADDLE LEAD SEEMED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8233930 ↗
• MalfunctionJan 9, 2019Intermittent Continuity; Failure to Deliver Energy; Failure to Interrogate; Communication or Transmission Problem; Connection Problem; Impedance Problem; Therapeutic or Diagnostic Output Failure; Intermittent Continuity; Failure to Deliver Energy; Failure to Interrogate; Communication or Transmission Problem; Connection Problem; Impedance Problem; Therapeutic or Diagnostic Output Failure

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT VIA MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT PATIENT'S STIM STOPPED WORKING AND COMES ON AND OFF INTERMITTENTLY. WIRELESS EXTERNAL NEUROSTIMULATOR (WENS) ALSO UNABLE TO COMMUNICATE WITH PATIENT CONTROLLER AND OUT OF REGULATION (OOR) BEING SHOWN WITHOUT ALLOWING PATIENT TO TURN DEVICE DOWN. THE CAUSE WAS UNKNOWN. TROUBLESHOOTING INVOLVED CHANGING BATTERY IN THE PATIENT CONTROLLER. IMPEDANCES CHECKED SHOWING NONE BUT CONNECTION ISSUE ON CONTACT 4. TRIED RE-SEEDING SEVERAL TIMES WITH NO LUCK. ATTEMPTED TO DISCONNECT PATIENT CONTROLLER AND RE-CONNECTING BUT CONTINUED TO NOT ALLOW PATIENT TO TURN AMPLITUDE DOWN. WENS WAS REPLACED AFTER TROUBLESHOOTING ALL OPTIONS. AFTER WENS WAS REPLACED, ABLE TO ADJUST AMPLITUDE TO PATIENT¿S LIKING. PATIENT IMMEDIATELY REPORTING IMPROVED PAIN CONTROL. THE ISSUE WAS RESOLVED. HCP HAD NO FURTHER INFORMATION. PATIENT'S WEIGHT WAS ASKED BUT UNKNOWN. THE PRODUCT WAS GOING TO BE RETURNED. NO SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient; Therapeutic Effects, Unexpected

  MAUDE report 8231249 ↗
• InjuryJan 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A TRIAL PATIENT IN A CLINICAL STUDY (SDY). IT WAS REPORTED THAT, WHEN THE TRIAL LEAD WAS EXPLANTED ON (B)(6) 2018, THERE WAS A PURULENT DISCHARGE NOTED. THE CLINICAL DIAGNOSIS WAS INFECTION/CELLULITIS. THE PATIENT WAS REFERRED TO THE ER TO RULE OUT SEPSIS. NO DEVICE ISSUES OR FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. ON (B)(6) 2018 (REP): NO NEW INFORMATION.

  Patient problems: Cellulitis; Purulent Discharge; Sepsis; Staphylococcus Aureus; Unspecified Infection

  MAUDE report 8209123 ↗
• MalfunctionDec 26, 2018Energy Output Problem; Positioning Problem; Energy Output Problem; Positioning Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT THEY SPOKE WITH THE TRIALING PROVIDER ABOUT THE PATIENT AND AT THE PATIENT¿S LAST FOLLOW UP APPOINTMENT ON 2018-12-27, THE PATIENT WAS ONLY REPORTING HIS NORMAL PRETRIAL PAIN LEVEL AND PAIN AREAS. THE REP REPORTED THAT THE PATIENT HAD BEEN REFERRED FOR A PUMP TRIAL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Burning Sensation; Discomfort; Pain

  MAUDE report 8196526 ↗
• MalfunctionNov 12, 2018Impedance Problem; Impedance Problem

  INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WITH A WIRELESS EXTERNAL NEUROSTIMULATOR (WENS) FOR AN UNKNOWN INDICATION FOR USE. IT WAS REPORTED THAT THE REP REPORTED GETTING FOUR TO FIVE ELECTRODES ON EACH LEAD THAT WERE OUT DURING THE CONNECTIVITY CHECK. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) TRIED WIPING DOWN THE LEAD AND THEN REINSERTING IT. HOWEVER, WHEN THE REP CHECKED THE IMPEDANCES AGAIN EVERYTHING WAS STILL OUT, ALTHOUGH THEY STATED THAT SOME GAVE THEM ¿ORANGE¿. THE HCP THEN PROCEEDED TO MOVE THE NEEDLE, BUT THINGS WERE THE SAME. THE REP STATED THAT THE HCP THEN REPLACED THE WENS AND THEY HAD THE SAME IMPEDANCE ISSUE. THE HCP THEN REPLACED THE LEAD AND THE CONNECTIVITY WAS THEN GREAT AND THE IMPEDANCES WERE WITHIN LIMIT. IT WAS DISCUSSED THE POTENTIAL FOR TEMPORARY HIGH IMPEDANCES WHEN THERE IS A LOSS OF RESISTANCE USED WITH AIR, AS WELL AS STERILE WATER. IT WAS REVIEWED WITH THE REP THAT IT WAS NOT UNUSUAL TO ENCOUNTER TEMPORARY HIGH IMPEDANCES DUE TO AIR. IF THE HCP KNOWS THAT THE LEAD PLACEMENT WAS GOOD, THEN THEY COULD CHOOSE TO LEAVE THE LEAD AS IS, BUT IT WAS UP TO THEM TO REPLACE THE EQUIPMENT AT THIS POINT. TECHNICAL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8061303 ↗
• MalfunctionOct 29, 2018Positioning Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IN A CLINICAL STUDY WITH AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THAT THE LEADS WERE UNABLE TO BE PLACED DURING IMPLANT AND WERE EXPLANTED. IT WAS NOTED THAT THE REASON FOR THIS WAS UNKNOWN AT THE TIME OF THE REPORT. THE PATIENT AS EXITED FROM THE STUDY ON (B)(6) 2018. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8015350 ↗
• InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURE REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT WITH A WIRELESS EXTERNAL NEUROSTIMULATOR (WENS). THE PATIENT HAD A MILD SEIZURE WHEN THEY GOT HOME AFTER THE TRIAL IMPLANT. THE REP THINKS IT COULD BE THE VERSED, FENTANYL AND ANESTHESIA THAT IS CAUSING THE SEIZURE. THE PATIENT HAS A COUPLE OF CATHETERS IN THEIR BACK. THE HEALTHCARE PROFESSIONAL (HCP) WOULD HAVE THE PATIENT TURN THE THERAPY BACK ON (B)(6) 2018. TECHNICAL SERVICES REVIEWED THAT THEY ARE NOT AWARE OF THE IMPLANT CAUSING SEIZURES. THE REP WOULD FOLLOW UP WITH THE HCP. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) ON (B)(4) 2018. THE REP INDICATED THAT THE CAUSE WAS UNKNOWN. NOW THE PATIENT AND THEIR SON ARE DOUBTING THAT THEY HAD A SEIZURE. NO ACTIONS WERE TAKEN TO RESOLVE THE SEIZURE. THE PATIENT¿S WEIGHT WAS UNKNOWN AT THE TIME OF THE EVENT. THIS INFORMATION WAS CONFIRMED WITH THE PHYSICIAN. NO FURTHER COMPLICATIONS WERE REPORTED/ARE ANTICIPATED.

  Patient problems: Seizures

  MAUDE report 8000928 ↗
• MalfunctionOct 22, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  10/18/2018 INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE, REGARDING A STIM TRIAL PATIENT. IT WAS REPORTED THAT PATIENT STOPPED RETURNING PHONE CALLS AFTER FIRST FIVE DAYS OF STIM TRIAL. HE DID NOT RESPOND TO REPEATED CALLS FROM THE REP OR THE PHYSICIAN'S OFFICE. AFTER APPROXIMATELY THREE WEEKS OF NO RESPONSES, THE POLICE WERE DISPATCHED TO HIS LISTED ADDRESS AND A REGISTER LETTER SENT TO A POST OFFICE BOX. THE REP GOT PATIENT ON THE PHONE AT APPROXIMATELY 1 MONTH AFTER THE SURGERY DATE. PATIENT IMMEDIATELY HUNG UP THE PHONE AND WOULD NOT RESPOND TO ADDITIONAL CALLS. JUDGE IN THE WORKERS COMP CASE ORDERED THE PATIENT TO REPORT TO THE PHYSICIAN¿S OFFICE. AT THAT COURT ORDERED APPOINTMENT, PATIENT INDICATED PUSS FORMED AT THE INCISION SITE AND REPORTS HE WENT TO THE ER. PATIENT PRESENTED THE LEADS SAYING THEY FELL OUT. IT IS BELIEVED THAT ANY INFECTION, IF IT OCCURRED AS REPORTED, WAS DUE TO THE LACK OF PATIENT COMPLIANCE. THE DEVICES WERE DISCARDED BY THE CUSTOMER. PATIENT'S WEIGHT WAS ASKED BUT UNKNOWN. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE EVENT DATE WAS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 7990300 ↗
• InjuryOct 10, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REPORTING THAT THE TRIAL PATIENT¿S DIAGNOSIS OR INDICATION FOR THEIR SCS (SPINAL CORD STIMULATION) THERAPY WAS POST LAMINECTOMY SYNDROME. IT WAS REPORTED THAT THE PATIENT¿S RESPONSE TO THEIR STIMULATION THERAPY WAS A SIGNIFICANT DECREASE IN PAIN. THE DOCTOR¿S RESPONSE REGARDING THE RELATIONSHIP BETWEEN THE LEAD MIGRATION AND THE PARALYSIS WAS OVER ¿STIM/TIME¿ (WORD WAS ILLEGIBLE AND FOLLOWING-UP FOR CLARIFICATION) IT WAS NOT ALLOWING THEM TO MOVE. THE LEAD WAS PULLED, AND THE SYMPTOMS RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION REGARDING THE PATIENT¿S MEDICAL HISTORY, MEDICAL RECORDS FROM THE LEAD PLACEMENT PROCEDURE AND RECORDS RELATED TO THE PATIENT¿S POST-OPERATIVE COURSE WERE REQUESTED BUT WERE NOT PROVIDED. IT WAS REPORTED THAT INFORMATION REGARDING THE PATIENT¿S ER VISIT (ER ADMISSION RECORDS, ASSESSMENT, DIAGNOSTICS, SURGICAL DICTATIONS ETC.) WERE AVAILABLE VIA THE UNIVERSITY ¿HOSPITAL¿ ADDITIONAL FOLLOW-UP WAS PERFORMED TO OBTAIN THIS INFORMATION. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Ambulation or Postural Difficulties; Muscle Weakness/Atrophy; Numbness; Pain; Paralysis

  MAUDE report 7952447 ↗
• MalfunctionSep 12, 2018High impedance; Impedance Problem; Adverse Event Without Identified Device or Use Problem; Therapeutic or Diagnostic Output Failure; High impedance; Impedance Problem; Adverse Event Without Identified Device or Use Problem; Therapeutic or Diagnostic Output Failure

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT VIA MANUFACTURER REPRESENTATIVE. CALLER REPORTED THE SCREEN DISPLAYS AN OUT OF REGULATION (OOR) MESSAGE AND SETTINGS NOT AVAILABLE ON CONTROLLER. CALLER HAD PATIENT CHANGE GROUPS AND ISSUE STILL OCCURRED OOR @ 1.2 - 1.4MA. CALLER INDICATED PATIENT IS VERY ACTIVE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. REP PROVIDED DEVICE SERIAL NUMBERS AND PATIENT INFORMATION. THE CAUSE OF OOR/SETTINGS NOT AVAILABLE WAS NOT DETERMINED. PATIENT WAS REPROGRAMMED AROUNDCONTACTS AND PATIENT WAS ABLE TO ADJUST WITH GREAT PAIN RELIEF. THE ISSUE WAS RESOLVED AND THE INFORMATION WAS CONFIRMED WITH THE HCP. ON (B)(6) 2018, REP REPORTED THAT PATIENT COMPLETED TRIAL TODAY AND WAS PRESENT FOR TRIAL LEAD REMOVAL. PHYSICIAN WANTS MANUFACTURER TO ANALYZE TRIAL LEADS AND WENS. DURING TRIAL PROCEDURE ON (B)(6) 2018, ONE ELECTRODE SHOWED AS "BAD" ON TABLET DURING IMPLANT WITH UNKNOWN IMPEDANCE VALUES, CONTACT NUMBER OR OTHER INFORMATION ABOUT IT. CALLER ALSO NOTED THAT LEADS WERE RESEATED ON WEDNESDAY, (B)(6) 2018 AND TWO MORE LEADS SHOWED AS "AVOID" WITH NO NOTED VALUES OR ELECTRODE NUMBERS. CALLER RAN IMPEDANCE TEST TODAY WHICH RESULTED IN THE FOLLOWING: ELE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7869035 ↗
• InjuryAug 8, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURE REPRESENTATIVE REGARDING A TRIAL PATIENT WITH A WIRELESS EXTERNAL NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING STROKE SYMPTOMS AND WENT TO THE EMERGENCY ROOM; WAS LATER ADMITTED TO THE HOSPITAL. THE PATIENT'S HCP PULLED THE LEADS AND AN HOUR AFTER THE LEAD PULL THE PATIENT 'SNAPPED BACK TO THEIR OLD SELF.' IT WAS NOTED THAT THE TRIAL WAS SUCCESSFUL IN GIVING THE PATIENT RELIEF. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE REP REPORTED THAT IF THERE WAS A RELATIONSHIP BETWEEN THE STROKE SYMPTOMS AND THE DEVICE/THERAPY, NO ONE THEY HAD SPOKEN TO COULD EXPLAIN IT. IT WAS NOTED THAT THE PATIENT DID NOT EXPERIENCE ANY RESIDUAL EFFECTS AND THAT THE ISSUE HAD RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Complaint, Ill-Defined; Stroke/CVA

  MAUDE report 7763757 ↗
• MalfunctionAug 3, 2018Unintended Collision

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT. IT WAS REPORTED THAT THE PATIENT WAS IN A CAR ACCIDENT DURING THEIR CERVICAL SPINAL CORD STIMULATOR (SCS) TRIAL WHILE THE WIRELESS EXTERNAL NEUROSTIMULATOR (WENS) WAS ON. THE STIM COVERAGE CHANGED AFTER THE CAR ACCIDENT; THEY WERE NOT GETTING STIM COVERAGE IN HER SHOULDERS OR NECK ANYMORE BUT WERE STILL GETTING COVERAGE IN HER ARMS AND HANDS. THE PATIENT WAS INSTRUCTED TO TURN THE STIM OFF WHILE DRIVING BUT THE PATIENT STATED THAT SHE DID NOT WANT TO TURN THE TRIAL STIM OFF BECAUSE SHE DIDN¿T LIKE THE SURGING FEELING WHEN TURNING IT BACK ON. THE REP THEN NOTED THAT THEY DISCUSSED TURNING THE STIM DOWN BEFORE TURNING IT BACK ON TO PREVENT THIS FROM HAPPENING. THE PATIENT ALSO NOTED THAT THEY FELT AS THOUGH BOTH THE TRIAL WENS AND THEIR EXISTING LUMBAR IMPLANTABLE NEUROSTIMULATOR (INS) WERE NOT FUNCTIONING IN THE SAME WAVE LENGTH AS BOTH THE TRIAL WENS AND THE INS WERE ON DURING THE CAR ACCIDENT. DUE TO THE DIFFERENCE IN WAVELENGTH, THE PATIENT REPORTED THAT THIS MADE HER WOBBLY BY AMBULATORY AND MADE IT DIFFICULT TO DRIVE IN A STRAIGHT LINE. TO RESOLVE THE ISSUE, THE TRIAL SYSTEM WOULD BE RE

  Patient problems: Ambulation or Postural Difficulties; Complaint, Ill-Defined; No Known Impact Or Consequence To Patient; Therapeutic Effects, Unexpected

  MAUDE report 7749353 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P840001. One submission often covers many models, so check the product and lot details in each record.

• Z-0372-2025 · Sep 18, 2024 · Open, Classified
  Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used wi
• Z-1691-2024 · Mar 28, 2024 · Open, Classified
  Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
• Z-0780-2024 · Dec 19, 2023 · Open, Classified
  Model A710 Intellis Clinician Programmer Application, version 2.0.97
• Z-2159-2021 · Jul 9, 2021 · Open, Classified
  Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
• Z-1926-2016 · May 3, 2016 · Terminated
  Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intractable pain of the trunk and/or li
• Z-1147-2015 · Jan 9, 2015 · Terminated
  The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or m
• Z-1524-2014 · Feb 27, 2014 · Terminated
  Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced
• Z-0278-2014 · Sep 30, 2013 · Terminated
  Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.
• Z-1536-06 · Aug 2, 2006 · Terminated
  Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis