SYNCHROMED® II 8637-40 (UDI 00643169508156)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3,054 adverse event reports that list this exact device (DI 00643169508156), received between Nov 9, 2016 and Sep 29, 2026 — classified as 10 deaths, 2,053 injuries, 991 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (421 reports).

2 FDA recall records name this device's identifier, 2 still open.

38 other recalls cover devices cleared under the same FDA submission (P860004); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 13, 2023Open, Classified

   Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling.

   Z-0615-2024 · Root cause: Under Investigation by firm · FDA record ↗

2. Aug 9, 2017Open, Classified

   Medtronic implemented a final design change intended to address the motor stall due to corrosion and is recalling devices with the previous design that are not implanted.

   Z-0896-2018 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 3,054 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  Patient problems: Bacterial Infection; Device Embedded In Tissue or Plaque

  MAUDE report 50937164 ↗
• InjurySep 22, 2026Insufficient Flow or Under Infusion; Insufficient Device Problem Information

  Information was received from a patient's representative (caller) regarding a patient who was receiving an unknown Baclofen via an i mplantable pump for intractable spasticity It was reported that the caller (patient's representative) reported that the pump was still installed but the patient had not had medication for about 6 years. The caller mentioned they had a really difficult time with a couple of revisions and the doctor recommended to leave the pump in, in case they wanted to revisit getting the catheter reinstalled. The caller said they were at the point that they wanted to consider it and they were looking for providers that were close in Colorado. The agent emailed the physician listings to the caller.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854004 ↗
• InjuryAug 25, 2026Obstruction of Flow; Infusion or Flow Problem

  Information was received from multiple sources (Healthcare Provider, Clinical Study) regarding a patient who was receiving Gablofen via an implantable pump. It was reported that the patient experienced agitation, itching in groin and increased tone. Baclofen withdrawal suspected. The patient was treated with oral baclofen and oral valium, 65 mcg single bolus of baclofen given via pump. The patient responded to bolus with decreased tone, decreased agitation, decreased clonus, and decreased itching. The Baclofen dose was serially increased from 271.5 mcg/day to 622 mcg/day over a 2 year period. On (b)(6) 2022 a Dye study was completed in preparation for pump replacement. During replacement surgery tissue noted around pump connector, requiring the spinal portion to be cut from pump. After replacement of spinal segment, slow egress of cerebrospinal fluid (CSF) noted, a kink in the catheter was identified and resolved with repositioning and anchoring of catheter connector. CSF flow improved post revision compared to pre-revision.

  Patient problems: Insufficient Information; Irritability; Itching Sensation; Muscular Rigidity

  MAUDE report 50434123 ↗
• InjuryMay 11, 2026Fluid/Blood Leak

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING HYDROMORPHONE (10MG/ML AT 1.498MG/DAY) VIA THEIR IMPLANTABLE INFUSION PUMP FOR NON-MALIGNANT PAIN. THE HCP PROVIDED PATIENT APPOINTMENT RECORDS. IT WAS REPORTED IN THE 'HOSPITALIZATIONS' SECTION OF THE PATIENT'S MEDICAL RECORD THAT THE PATIENT HAD A PAIN PUMP LEAK (B)(6) 2020, AND NARCAN WAS ADMINISTERED BUT THE PATIENT WAS NOT ADMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25139007 ↗
• MalfunctionMar 19, 2026Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING AN UNKNOWN MEDICATION VIA AN IMPLANTED PUMP. THE INDICATION FOR PUMP USE WAS NON-MALIGNANT PAIN. THE PATIENT REPORTED THAT THE PUMP ¿ALWAYS FLIPPED WHEN THEY GOT IN A CERTAIN POSITION OR WHATEVER¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638440 ↗
• MalfunctionFeb 24, 2026Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE PUMP. THE PATIENT THOUGHT THE PUMP DRUG WAS DILAUDID OR HYDROMORPHONE. THE INDICATION FOR USE WAS SPINAL PAIN. THE PATIENT REPORTED THAT THEY¿VE HAD INTERMITTENT ISSUES CONNECTING TO THE PUMP ¿SINCE I GOT IT¿ THEN ¿MAYBE NOT RIGHT IN THE BEGINNING.¿ THE PATIENT STATE IT TAKES 5 MINUTES TO GET A BOLUS AND ¿SOMETIMES IT WILL SIT AT 91% FOR 4 MINUTES.¿ THE PATIENT JUST HAD SURGERY AND CONFIRMED IT WAS UNRELATED TO MDT PUMP/THERAPY AND STATED ANESTHESIOLOGY CONNECTED WITH THEIR MDT CONTROLLER, IT GOT A LITTLE BIT BETTER. THE AGENT ASSISTED THE PATIENT IN CONNECTING TO PUMP AND REVIEWED CONSIDERATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430186 ↗
• InjuryDec 19, 2025Obstruction of Flow; Obstruction of Flow

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER STATING THAT THE CATHETER OCCLUSION WAS FIRST OBSERVED ON (B)(6) 2025 AND THE CAUSE WAS NOT DETERMINED. A DYE STUDY WAS PERFORMED AND THE PORT SHOWED CONTRAST COLLECTED AROUND THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857912 ↗
• MalfunctionDec 8, 2025Material Integrity Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING INTRATHECAL SALINE VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY. THE HCP REPORTED THE PATIENT'S PUMP WAS NO LONGER IN USE DUE TO A CATHETER FRACTURE THAT WAS DISCOVERED IN 2022. AT SOME POINT AFTER THAT, SALINE WAS PUT INTO THE PUMP AND IT WAS TURNED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23737874 ↗
• InjuryOct 22, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS RECEIVING MORPHINE DRUG VIA AN IMPLANTABLE PUMP FOR SPINAL PAIN INDICATIONS FOR USE. IT WAS REPORTED THAT ONE TIME, THE PATIENT LET THE PUMP GO TOTALLY EMPTY AND THE PATIENT WENT INTOWITHDRAWAL. THE PATIENT STATED THAT THEY ENDED UP IN THE HOSPITAL. WHEN ASKED FOR AN EVENT DATE, THE PATIENT STATED THAT "WHEN I GOT IT CHANGED IN 2014, (B)(6)" AND THAT THEY WERE ON THEIR 3RD PUMP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23364180 ↗
• InjuryJun 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WITH AN IMPLANTABLE PUMP INFUSING UNKNOWN BACLOFEN FOR INTRACTABLE SPASTICITY. IT WAS REPORTED THAT THE PATIENT STATED THE SEWING JOB WAS BAD SO THAT IT CAME OUT FOR THE PUMP IMPLANTED 10 YEARS AGO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22215701 ↗
• MalfunctionApr 14, 2025Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  ON 2025-MAR-20, INFORMATION WAS RECEIVED FROM A PATIENT RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE PUMP FOR SPINAL PAIN. THE PATIENT REPORTED THE PUMP QUIT WORKING OVER A YEAR AGO AND THEY WANTED TO HAVE THE PUMP TAKEN OUT OR REPLACED BUT THE THEN MANAGING PHYSICIAN TOLD THE PATIENT THEY HAD VERY LITTLE CARTILAGE IN THEIR SPINE AND THAT HE WAS LOW ON SPINAL FLUID. THE PATIENT WAS NOT SURE IF THEY COULD HAVE THE PUMP REPLACED OR NOT. THE PATIENT FIRST STATED THE PUMP STOPPED DUE TO NORMAL BATTERY DEPLETION BUT THEN LATER STATED THE PUMP STOPPED PRIOR TO THE 7 YEARS. THE PATIENT STATED THE HEALTHCARE PROFESSIONAL (HCP)REPLACES THE PUMP AT 5 YEARS AND AFTER THAT HE WILL NOT FILL THE PUMP. THE AGENT REVIEWED PUMP LONGEVITY. THE PATIENT MENTIONED THEY HAD COLON CANCER AND HAD AN ENORMOUS AMOUNT OF CHEMO AND RADIATION FOR 2 YEARS WHICH IS WHY HE HAS NO CARTILAGE BETWEEN ALL OF HIS VERTEBRAE BUT THE HCP WHO WAS MANAGING THE PUMP RAN A CATHETER ROUND AND PUT IT IN THE SPINE. THE PATIENT THEN STATED THE HCP SHOWED HIM ON THE X-RAY THAT THEY HAVE LOW SPINAL FLUID AND THEY DID NOT KNOW IF THEY HAVE THE CATHETER IN THE SPINAL FLUID OR NOT. THE PATIENT WAS NOT SURE IF THEY SHOULD PUT ANOTHER

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21835038 ↗
• InjuryApr 10, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS RECEIVING UNKNOWN DRUG VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PUMP WAS REPLACED BEFORE THE BATTERY WAS DEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21822356 ↗
• MalfunctionMar 10, 2025Device Alarm System; Device Alarm System

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE (REP) VIA A REGARDING A PATIENT RECEIVING INTRATHECAL BACLOFEN (UNKNOWN) 2000 MCG/ML AT UNKNOWN DOSE VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. THE COMPANY REPRESENTATIVE (REP) REPORTED THAT PATIENT HAD PUMP REFILLED ON MONDAY AND AT THAT TIME THE PUMP HAD REACHED THE LOW RESERVOIR STATUS. AFTER PUMP WAS FILLED AND UPDATED WITH THE PROGRAMMER THE PATIENT STATED THAT THE PUMP CONTINUED TO ALARM. AGENT REVIEWED INFORMATION REGARDING CONCURRENT ALARMS AND ADVISED COMPANY REP ON HOW TO USE ACTIVE ALARM OPTION ON THE HOME SCREEN TO SILENCE THE CURRENT ALARM. THE TROUBLESHOOTING STEPS THAT WERE TAKEN ON THE CALL RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21559879 ↗
• InjuryJan 21, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIVING BUPIVACAINE 0.09 MG/DAY 0.3 MG/DAY DILAUDID (HYDROMORPHONE) 153 MCG/DAY 500MG/ML VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PUMP FEELING LIKE THE PUMP MOVED AROUND WHEN SHE WAS ACTIVE. SHE COMPLAINED THAT IT CAN BE SOMEWHAT PAINFUL AROUND THE LATERAL EDGE OF THE PUMP POCKET WHEN SHE WAS ACTIVE. THERE WERE NO KNOWN ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. TROUBLESHOOTING WAS NOT PERFORMED. ON (B)(6) 2025, THE PHYSICIAN REORIENTED THE PUMP SO THAT THE ACCESS PORT WAS ORIENTED MORE MIDLINE IN THE EXISTING RIGHT ABDOMINAL POCKET AND RE-ANCHORED THE PUMP IN PLACE. THE ISSUE WAS RESOLVED. THERE WAS NO FURTHER INFORMATION FROM THE HEALTHCARE PROVIDER. THE PATIENT WAS ALIVE AND NO INJURY.

  Patient problems: Pain

  MAUDE report 21200302 ↗
• MalfunctionJan 8, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A PATIENT RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE PUMP. THE INDICATIONS FOR USE WAS SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT STATED THE LAST TIME THE PUMP WAS REFILLED WAS IN NOVEMBER FOUR YEARS AGO DUE TO UNRELATED MEDICAL ISSUES. THE PATIENT STATED THEY WERE NOT GOING THROUGH ANY WITHDRAWALS AND THEIR BACK WAS NOT BOTHERING THEM SO THEY CHOSE NOT TO HAVE THE PUMP FILLED AND EVEN CONSIDERED HAVING THE PUMP REMOVED. THE PATIENT STATED "ABOUT THE LAST 2-3 YEARS" THE PUMP HAS BEEN CAUSING HER A LOT OF PAIN. THE PATIENT STATED THE PUMP HAD MOVED OVER THE YEARS AND WHEN THEY BENT OVER, THE PUMP GOES UP INTO THEIR RIBS CAUSING THEM A LOT OF PAIN; HOWEVER, THEY COULD NOT FIND ANY DR WHO WOULD "TOUCH THEM". THE PATIENT STATED THEY THOUGHT THE DOCTORS DID NOT WANT THE LIABILITY OF THE CATHETER BEING LEFT IN THE BODY. THE PATIENT STATED NOW THEY WERE HAVING TROUBLE WITH THEIR FEET AND WAS ALSO HAVING BACK PAIN. THE PATIENT STATES THE DOCTOR TOLD THEM BECAUSE OF THE FEET PAIN, THEY WERE NOT WALKING CORRECTLY W HICH WAS CAUSING THE BACK PAIN. THE PATIENT STATED THEY HAS NOT HAD BACK PAIN THIS BAD IN MANY YEARS AND IT WAKES THEM UP IN THE MIDDLE OF THE N

  Patient problems: Ambulation or Postural Difficulties; Pain; Sleep Dysfunction

  MAUDE report 21107783 ↗
• InjuryOct 29, 2024Infusion or Flow Problem; Material Integrity Problem; Infusion or Flow Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WHO WAS RECEIVING UNKNOWN DRUG VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE BACLOFEN PUMP WAS REPLACED FOR END OF SERVICE. AFTER CATHETER WAS DISCONNECTED FROM PRIOR PUMP, NO CEREBROSPINAL FLUID FLOW NOTED. CATHETER CONNECTED TO NEW PUMP WITH SMALL AMOUNT OF FLUID ASPIRATED ALONG WITH AIR. A HOLE WAS DISCOVERED IN THE SPINAL SEGMENT. THE CATHETER WAS REPLACED RESULTING IN MINIMAL FLOW OF CEREBROSPINAL FLUID WITH NO AIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20557219 ↗
• InjurySep 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING INTRATHECAL UNKNOWN DRUG VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE REASON DEVICE RETURN WAS DUE TO A MALFUNCTION. THE REP STATED THAT THE PHYSICIAN FINAL REPORT WAS AVAILABLE FOR ANY WARRANTY DETERMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146652 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT RECEIVING INTRATHECAL UNKNOWN DRUG VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT COMMENTED THAT THEY NO LONGER HAD THEIR PAIN PUMP, AND THAT THE DEVICE WAS REMOVED IN NOVEMBER OF 2023. NO ALLEGATIONS WERE MADE REGARDING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20126924 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT RECEIVING INTRATHECAL CLONIDINE, HYDROMORPHONE AND FENTANYL (ALL UNKNOWN CONCENTRATION AND DOSE) VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT'S WIFE (CALLER) STATED THAT BACK IN 2017, THEY WENT TO REPLACE THE PUMP AND ATTEMPTED TO REPLACE THE CATHETER BUT THE CATHETER WAS ENCAPSULATED AND SCARRED IN SO THEY COULD NOT REMOVE IT. THE CALLER STATED THAT THEY REMOVED THE PUMP AND LET IT HEAL, BUT THE PATIENT DEVELOPED A SEROMA AND AN OPEN WOUND. THE PATIENT'S WIFE STATED IT WAS A YEAR-LONG PROCESS TO HEAL AND THEY PLACED A NEW CATHETER AND PUMP IN 2018. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Scar Tissue; Seroma; Wound Dehiscence

  MAUDE report 20087951 ↗
• InjuryAug 21, 2024Obstruction of Flow; Obstruction of Flow

  INFORMATION WAS RECEIVED FROM A PATIENT RECEIVING INTRATHECAL HYDROMORPHONE, BUPIVACAINE, FENTANYL AND BACLOFEN (ALL UNKNOWN CONCENT RATION AND DOSES) VIA AN IMPLANTABLE PUMP FOR SPINAL PAIN. THE PATIENT STATED WHEN THEY GOT THEIR PUMP REPLACED IT WAS CLOGGED BECAUSE THEY WEREN'T GETTING RELIEF. THE PATIENT STATED THEIR PUMP WAS REPLACED IN MAY OF THIS YEAR DUE TO NORMAL BATTERY DEPLETION BUT ALSO DUE TO THE CATHETER CLOGGING. THE PATIENT STATED THEY'VE BEEN TELLING THEM FOR ABOUT A YEAR THAT THEY DIDN'T THINK THEY WERE GETTING A FULL BOLUS OR THEY DIDN'T THINK IT WAS RUNNING ALL THE TIME BECAUSE THEY WERE NOT GETTING THE RELIEF THEY THOUGHT THEY SHOULD BE GETTING. THE DOCTOR WENT IN AND FOUND OUT IT (THE CATHETER) WAS CLOGGED AND HAD TO CUT IT OFF AND LEAVE SOME OF IT IN THERE BECAUSE HE COULDN'T GET IT ALL OUT. THE PATIENT STATED THE HCP'S NAME BUT WAS UNSURE OF THE SURGEON'S NAME WHO DID THE SURGERY. THE PATIENT CONFIRMED THEY HAD THE SAME MEDICATION IN CURRENT PUMP THAT WAS USED IN PREVIOUS PUMP. THE PATIENT ALSO MENTIONED THEY USED A WALKER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20012052 ↗
• InjuryJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECIEVED FROM THE HEALTHCARE FACILITY REPORTING THAT THE PATIENT PUMP'S REACHED EOS AS EXPECTED. PATIENT WAS IN PROCESS OF HAVING REPLACEMENT SCHEDULED.

  Patient problems: Chills; Fever; Pain

  MAUDE report 19843017 ↗
• MalfunctionJul 25, 2024Mechanical Problem; Mechanical Problem

  THE PUMP WAS RETURNED WITH NO DOCUMENTATION/INFORMATION AND UNDERWENT ROUTINE ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19825924 ↗
• InjuryJul 22, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED FROM A PATIENT REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING INTRATHECAL BACLOFEN (UNKNOWN) AT UNKNOWN CONCENTRATION/DOSE VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY. IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL ON A VENTILATOR BECAUSE THE PUMP WAS OUT OF BACLOFEN AND HAD BEEN FOR MONTHS. THE PATIENT REP STATED THE PATIENT HAD BEEN FIGHTING WITH THE INSURANCE COMPANY AND DOCTORS AND MEDTRONIC FOR MONTHS TO GET THE PUMP REPLACED. IT WAS REPORTED THAT THE PATIENT HAD STIFF PERSON SYNDROME AND NOW WAS IN RESPIRATORY FAILURE AND THEY WERE TRYING TO TAKE THE PATIENT OFF THE VENTILATOR TODAY. THE PATIENT WAS PRETTY HEALTHY OTHERWISE AND WAS WORKING WITH THE HOSPITAL TO FIND A DOCTOR TO REPLACE THE PUMP. PATIENT SERVICE SPECIALIST ASKED IF THE PUMP HAD BEEN INTERROGATED AND PATIENT REP STATED THEY WERE TOLD BY SOMEONE THAT THE PUMP NEEDED TO BE REPLACED BUT THEY WERE NOT SURE WHO THAT WAS. PATIENT WAS ON BOTH DIAZEPAM AND DILAUDID AND THE PATIENT REP WAS WONDERING IF THEY COULD TAKE HER OFF OF EITHER OF THEM BECAUSE SHE HAD STIFF PERSONS SYNDROME AND THEY MIGHT NOT BE WILLING TO GIVE HER THE RIGHT MEDICATIONS. THE ISSUE WAS NOT RESOLVED THROUGH

  Patient problems: Respiratory Failure

  MAUDE report 19792489 ↗
• MalfunctionJul 8, 2024Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) AND COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING INTRATHECAL DILAUDID (22 MG/ML AT 3.702 MG/DAY) AND BUPIVACAINE (20 MG/ML AT 3.365 MG/DAY) VIA AN IMPLANTED PUMP FOR AN UNKNOWN INDICATION FOR USE. IT WAS REPORTED THAT THE HCP WAS UNABLE TO ASPIRATE CEREBROSPINAL FLUID (CSF). THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT COULD HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PUMP SEGMENT OF THE CATHETER WAS REPLACED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT AND THE PATIENT'S STATUS WAS "ALIVE-NO INJURY". THE PATIENT'S WEIGHT AND MEDICAL HISTORY WERE ASKED AND WOULD NOT BE MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690904 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER (CON) REGARDING A PATIENT RECEIVING INTRATHECAL BACLOFEN (UNKNOWN CONCENTRATION AND DOSE) VIA AN IMPLANTED PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYMPTOMS OF A POTENTIAL OVERDOSE AND WAS ADMITTED TO THE HOSPITAL (B)(6) 2021. THE HOSPITAL WAS NOT ABLE TO FIND ANYTHING WRONG WITH THE PATIENT. 2024-06-27 RTG0609702 UPDATE (CON) ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER (CON) REPORTING THAT THE DOCTOR "REFUSES" TO BELIEVE THERE IS SOMETHING WRONG WITH THE PUMP. THE CALLER INQUIRED IF THE PUMP CAN MALFUNCTION WITHOUT ALARMING. IT WAS REPORTED THAT ONE OF THE TIMES THE PATIENT WAS ADMITTED THE PATIENT WAS INTUBATED. IT WAS REPORTED THE PATIENT HAS HAD ALL THE SIGNS OF AN OVERDOSE.

  Patient problems: Insufficient Information

  MAUDE report 19657302 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P860004. One submission often covers many models, so check the product and lot details in each record.

• Z-2201-2026 · Apr 8, 2026 · Open, Classified
  Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900
• Z-1506-2025 · Jan 9, 2025 · Open, Classified
  A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
• Z-2352-2024 · May 10, 2024 · Open, Classified
  Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
• Z-0614-2024 · Nov 13, 2023 · Open, Classified
  Medtronic SynchroMed II, Model 8637-20, Programmable pump
• Z-0522-2024 · Jul 13, 2020 · Completed
  Medtronic SynchroMed, Model A10
• Z-0508-2020 · Oct 11, 2019 · Terminated
  Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
• Z-0537-2018 · Sep 21, 2017 · Terminated
  Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UDI: 00643169202153 The Ascenda Intrath
• Z-0788-2017 · Oct 3, 2016 · Terminated
  Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 Sy
• Z-1271-2016 · Feb 9, 2016 · Terminated
  Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
• Z-1681-2015 · Apr 10, 2015 · Terminated
  Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an
• Z-1062-2011 · Jan 14, 2011 · Terminated
  Medtronic SynchroMed EL (Model No: 8626 and 8627) implantable drug pump The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion
• Z-1061-2011 · Jan 14, 2011 · Terminated
  Medtronic SynchroMed implantable drug pump Refill Kits (Model No: 8551, 8555, 8561, 8562, 8564, 8565, 8566 The Model 8551, 8555, 8561, 8562, 8564, 8565, and 8566 Refill Kits ar
• Z-1060-2011 · Jan 14, 2011 · Terminated
  Medtronic SynchroMed II (Model No: 8637) implantable drug pump The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the follow
• Z-2276-2009 · Jul 1, 2009 · Terminated
  Medtronic SynchroMed II Programmable Pump, 8637, Rx Only, Sterilized by ethylene oxide gas, Medtronic inc., Minneapolis, MN 55432-5604. (The SynchroMed II Pump is supplied in 20 m
• Z-1214-2010 · Mar 23, 2009 · Terminated
  Medtronic N'Vision 8870 Application Card for use in the Medtronic model 8840 Physician Programmer. Manufactured for: Medtronic, Inc., Minneapolis, MN 55432-5604 USA.

…and 23 more.