ENTERRA® II 37800Recalls & reported problems

Summary

The FDA's MAUDE database contains 544 adverse event reports that list this exact device (DI 00643169614246), received between Nov 28, 2016 and Mar 12, 2024 — classified as 1 death, 358 injuries, 185 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (99 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 544 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2024Material Deformation; Insufficient Device Problem Information; Material Deformation; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THE HCP STATED AN X-RAY WAS DONE ON THE PT ON JULY 21ST AND IT WAS DISCOVERED THAT ONE OF THE PATIENT'S LEAD IS KINKED. HCP NOTES THEY SAW A MESSAGE COME UP WHEN FIRST ATTEMPTING TO INTERROGATE PATIENT'S INS WITH 8840: 'THERAPY MEASUREMENT IS OUT OF RANGE. IF PERFORMING AN IMPLANT CHECK THE LEAD INSERTION INTO THE NEUROSTIMULATOR'. TSS HAD THE CALLER PRESS 'CONTINUE' AND A FURTHER IMPEDANCE CHECK WAS DONE AND IT WAS NOTED MULTIPLE CONTACTS SHOWING >20K OHMS BUT ONE CONTACT PAIR SHOWED VIABLE - C/2 AT 510 OHMS. TSS HAD THE CALLER SWITCH PROGRAMMING TO THIS CONTACT PAIR (C+2-) AND THE PT IMMEDIATELY NOTED THEY FELT SIMULATION. CALLER THEN RAN A THERAPY IMPEDANCE MEASUREMENT AND IT SHOWED IN-RANGE VALUES (10V, 22MA, 44X OHMS). TSS ADVISED THEY SET STIMULATION TO A COMFORTABLE LEVEL AND SCHEDULE A TIME WITH THE REP ASAP. TSS REDIRECTED TO NAS AND PROVIDED NAS NUMBER. NO FURTHER COMPLICATIONS WERE REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885571 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT PATIENT SAID THEY ARE HAVING MAJOR COMPLICATION AND WOULD LIKE TO FILE A COMPLAINT. PATIENT SAID THE MEDICAL CENTER THEY WERE GOING TO "DUMPED ME". PATIENT SAID THEY DID A LOT OF TESTS AND THEY AREN'T SURE WHY. PATIENT SAID THE DEVICE IS CAUSING MAJOR COMPLICATIONS. PATIENT SAID THEY HAVE PELVIC ORGAN PROLAPSE AND ARE DEFECATING OUT THEIR ORGANS. PATIENT SAID THEY HAD THE WRONG THING IMPLANTED IN THEIR BODY. PATIENT SAID IT WAS UNETHICAL TO HAVE HAS SO MANY PEOPLE PUSH GOT T HEM TO GET A GASTRIC STIMULATOR. PATIENT SAID THEY ARE SUFFERING AND DEVICE DENIED CARE BECAUSE THEY HAVE THE DEVICE. PATIENT SAID THEY NEED TO HAVE THE SHUT OFF FOR A SURGERY. PATIENT WAS USING PROFANITY. EMAILED REP AND PATIENT RELATIONS. AGENT DID NOT ASK ABOUT THE CIRCUMSTANCES THAT LED TO THE REPORTED ISSUE.

  Patient problems: Insufficient Information; Prolapse

  MAUDE report 18851207 ↗
• InjuryMar 6, 2024Energy Output Problem; Energy Output Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT PATIENT MENTIONED THEY HAD THE TRIAL PLACED ON THE 23RD. THE PATIENT STATES ON THE 28TH THEY NOTICED HAVING TINGLING IN THE LOWER SPINE AND PAIN ON THE SAME SIDE AS THE INS AND IN THE LEFT LEG. PATIENT STATES THEY HAVE SWELLING IN THE MIDDLE OF THE BACK BUT THE UPPER BACK IS WHERE IT STARTED. PATIENT STATES THEY WERE ADMITTED INTO THE HOSPITAL AND THEY DECIDED TO TURN THE STIMULATOR OFF FOR A FULL DAY. THE PATIENT STATES THEY DECIDED TO TURN STIM BACK ON AND WHEN THEY DID, THEY EXPERIENCED A DRAMATIC CHEST AND BACK PAIN. THE PATIENT STATES IT WAS ALMOST NEAR THEIR SHOULDER. THE PATIENT MENTIONED THE CHEST PAIN HAD STARTED ABOUT 3 WEEKS PRIOR TO HAVING THE EXTERNAL DEVICE PUT IN BUT THE PAIN WAS SO BAD LAST NIGHT THAT THEY THOUGHT THEY WERE HAVING A HEART ATTACK. THE PATIENT STATES THEY ENDED UP TURNING STIM OFF AND THEY DID FEEL BETTER BUT DID VOMIT. THE PATIENT STATES THEY HAD AN EKG BUT IT CAME BACK NORMAL. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Pain; Swelling/ Edema; Vomiting

  MAUDE report 18849915 ↗
• InjuryJul 21, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A OTHER, REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). FOR GASTRIC STIMULATION. IT WAS REPORTED, THAT THE LEADS WERE PULLED FROM THE STOMACH AND FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370318 ↗
• InjuryMay 19, 2023Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THEY HAVE HAD 3 BUT UNFORTUNATELY, IT DID NOT HELP THEM WITH THEIR SYMPTOMS. THE PATIENT STATED THAT THE GTUBE GOT TANGLED WITH THE LEADS AND THEY HAVE TO HAVE IT REMOVED AND HAD TO PACK THE WHOLE IN THEIR ABDOMEN UNTIL IT WAS HEAL.

  Patient problems: Erythema; Insufficient Information; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 16969307 ↗
• InjuryMay 16, 2023High impedance; Adverse Event Without Identified Device or Use Problem; High impedance; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THAT THE CAUSE OF THE HIGH IMPEDANCE WAS UNKNOWN. THE STEPS TAKEN TO RESOLVE THE ISSUE WERE NOTED TO BE "(B)(6) 2023 DOCTOR TRIED CHANGING THE BATTERIES TO NO EFFECT. DEVICE WAS REPLACED." IT WAS NOTED THAT THE ISSUE HAS BEEN RESOLVED.

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

  MAUDE report 16940084 ↗
• InjuryMay 10, 2023Migration or Expulsion of Device; Inappropriate/Inadequate Shock/Stimulation; Migration or Expulsion of Device; Inappropriate/Inadequate Shock/Stimulation

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE PATIENT WAS SEEN BY THEIR DR ON (B)(6) FOR A POTENTIAL DEVICE ADJUSTMENT. PATIENT STATED THAT HER SYMPTOMS HAD RETURNED, AND THAT THEIR HEALTH CARE PROFESSIONAL (HCP) HAD PREVIOUSLY TOLD HER THAT HER LEADS HAD ERODED INTO THE LUMEN OF HER STOMACH. HOWEVER, HCP CAME IN AND CONFIRMED THAT THIS WAS SIMPLY A MISCOMMUNICATION. THAT HE HAD PREVIOUSLY TOLD HER THAT LEAD EROSION WAS A POTENTIAL REASON FOR SYMPTOM RETURN, NOT THAT THIS PATIENT'S LEADS HAD ERODED .THEY INTERROGATION OF THE PATIENT'S STIMULATOR WITH AN 8840 PROGRAMMER REVEALED IMPEDANCE WAS WITHIN NORMAL RANGE. HCP RECOMMENDED A ONE STEP UP IN THE ENERGY ALGORITHM, WHICH I PERFORMED ON THE 8840 UNDER HIS SUPERVISION. PATIENT WAS SEEN A MONTH LATER IN HIS CLINIC AGAIN, AND STATED THAT HER SYMPTOMS HAD IMPROVED, BUT WERE STILL PRESENT. PATIENT HAS A FOLLOW UP APPOINTMENT WITH DR. HUGHES' CLINIC IN AUGUST, BUT THE LEADS AND DEVICE ARE STILL ACTIVE AND IN SERVICE.

  Patient problems: Electric Shock; Erosion; Internal Organ Perforation; Vomiting

  MAUDE report 16904075 ↗
• InjuryMay 2, 2023Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION. IT WAS REPORTED THAT THEY TOOK OUT THE PATIENT'S STOMACH AND GALLBLADDER. THEY LIVE ON A J TUBE FEEDING PUMP NOW. THEY LOST 130LBS IN A YEAR AND ALL THEIR TEETH FROM VOMITING. THEY HAVE SLOW INTESTINAL MOTILITY AND SLOW ESOPHAGEAL MOTILITY. THEY CAN'T EAT SOLIDS ANYMORE. THEY TRIED THE DEVICE, BUT THE LEADS HAD SLIPPED FROM THEIR STOMACH LINING AND TORE 85% OF THEIR STOMACH. THEY ARE ON PALLIATIVE CARE NOW.

  Patient problems: Insufficient Information; Internal Organ Perforation; Vomiting; Weight Changes

  MAUDE report 16853740 ↗
• InjuryMay 2, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT RECENT INTERROGATION OF THEIR STIMULATOR REVEALED THAT THE LEADS HAD FAILED SUGGESTING THAT MAYBE ONE WAS FRACTURED. THE OLD GENERATOR AND LEADS WERE REPLACED. THERE WERE NO COMPLICATIONS AND THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852966 ↗
• InjuryApr 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION. IT WAS REPORTED THAT THE PATIENT HAS BEEN IN THE HOSPITAL A LOT AND THEY ARE THINKING MAYBE THIS IS CAUSED BY THE STIMULATOR AND/OR MAYBE THE BATTERY NEEDS TO BE CHANGED. PATIENT SAID THEY ARE IN THE HOSPITAL NOW.

  Patient problems: Insufficient Information

  MAUDE report 16708228 ↗
• MalfunctionMar 31, 2023Migration or Expulsion of Device; Battery Problem; Migration or Expulsion of Device; Battery Problem

  IT WAS REPORTED THAT THE PATIENT HAS BEEN HAVING INCREASED NAUSEA AND VOMITING FOR THE PAST 2 MONTHS. THE PATIENT HAS AN APPOINTMENT WITH A SURGEON FOR EVALUATION.

  Patient problems: Nausea; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16656303 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED (B)(6), 2021 BECAUSE IT CAUSED MORE PROBLEMS THAN IT WAS HELPING, BUT THE LEADS REMAIN IN. REVIEWED NO MRI WITH THE LEADS.

  Patient problems: Insufficient Information

  MAUDE report 16628536 ↗
• InjuryMar 24, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT'S HEALTHCARE PROVIDER (HCP). IT WAS REPORTED THAT THE STEPS TAKEN TO RESOLVE THE ISSUE INCLUDED THE DEVICE TURNED OFF ON (B)(6) AND TURNED BACK ON ON (B)(6). IT IS UNKNOWN IF THE ISSUE WAS RESOLVED.

  Patient problems: Discomfort; Electric Shock; Nausea

  MAUDE report 16615282 ↗
• InjuryMar 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION. IT WAS REPORTED THAT THE DEVICE DIDN¿T WORK AT ALL FOR THEM SO THEY HAD IT TAKEN OUT.

  Patient problems: Insufficient Information

  MAUDE report 16563975 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR AND GASTRIC STIMULATION. IT WAS REPORTED THAT THE PATIENT CONTINUES TO BE RE-ADMITTED TO THE HOSPITAL FOR GASTROPARESIS SYMPTOMS OF NAUSEA AND VOMITING. CALLER STATED THE PATIENT HAS BEEN UNFOLLOWED BY A PHYSICIAN SINCE IMPLANT AND THE RETURN OF SYMPTOMS/HOSPITAL ADMISSIONS HAS BEEN WITHIN THE LAST YEAR OR SO. THE CALLER WAS NOT WITH THE PATIENT. THE CALLER WAS REDIRECTED TO NAS.

  Patient problems: Nausea; Vomiting

  MAUDE report 16457076 ↗
• InjuryFeb 9, 2023Battery Problem; Battery Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION. THE REASON FOR CALL WAS PATIENT SAID THEY ARE IN THE HOSPITAL. IT WAS REPORTED THAT THEY THINK THE INS MIGHT BE DEAD OR IS NOT WORKING PROPERLY. PATIENT CAME TO THE HOSPITAL ON TUESDAY. PATIENT SAID THEY THOUGHT IT SOMETHING ELSE BUT NOW THINKS THE DEVICE MAYBE THE REASON THEY ARE SO SICK. PATIENT WAS TOLD IN JUNE THAT THEY WERE AT THE HIGHEST SETTING. PATIENT TEXT MESSAGED THE MANUFACTURING REPRESENTATIVE (REP) WHO SAID THE DEVICE IS LIKELY DEAD. PATIENT SAID THE REP IS IN FLORIDA TILL NEXT WEEK. PATIENT ASKED IF THERE IS SOMEONE ELSE WHO CAN COME CHECK THE DEVICE. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 16333740 ↗
• InjuryFeb 8, 2023Malposition of Device; Malposition of Device

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT PATIENT HAD THE GASTRIC STIMULATOR¿ PLACED IN JUNE 2018 AND DID FIND THE DEVICE DID NOT  HELPED DECREASE HER NAUSEA AND VOMITING AT ALL, DESPITE BEING ADJUSTED TO THE HIGHEST LEVELS. AND DECIDED TO REMOVE THE DEVICE IN MAY 2022  AND THE DR COMPLETED THE REMOVAL AND STATED THE DEVICE APPEARED TO BE ¿IMPLANTED INCORRECTLY¿ AND ¿THE LEADS WERE PLACED ON THE TOP PART OF THE STOMACH AND NOT THE BOTTOM PART¿ AND THAT IS WHY SHE WAS NOT FEELING RELIEF. PT IS RE-CONSIDERING AN IMPLANT AT THIS TIME IF THE DEVICE CAN BE CORRECTLY PLACED.  NO FURTHER INFORMATION PROVIDED AND DO NOT HAVE ANY FURTHER INFORMATION REGARDING SERIAL NUMBER OF DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16321705 ↗
• InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR THERAPY. IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED ON (B)(6) 2023. THE PATIENT HAS AN INFECTED POCKET. SURGEON LEFT THE LEADS IN TO COME BACK AND IMPLANT A NEW BATTERY ONCE WOUND HAS HEALED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16311816 ↗
• MalfunctionJan 4, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION. IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING SHOCKING FROM THEIR DEVICE. THEIR DEVICE WAS SHUT OFF AND IS NO LONGER CAUSING SHOCKING. THEY WERE RETURNING ON 12/20. AT THAT TIME THEY WILL DETERMINE WHETHER TO REPLACE HER DEVICE OR TO REMOVE IT.

  Patient problems: Electric Shock

  MAUDE report 16098598 ↗
• InjuryJan 3, 2023Overheating of Device; Overheating of Device

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR THERAPY. IT WAS REPORTED THAT THE REASON FOR THE CALL WAS TO ASK ABOUT ADVERSE EVENTS WITH THE IMPLANT. PATIENT SAID THAT, IN MARCH, THEY NOTICED SOME REDNESS AND BRUISING UNDERNEATH THE NEUROSTIMULATOR, HOWEVER THEY SAID THAT IT WENT AWAY. ABOUT A MONTH AGO OR SO, PATIENT HAD A REAL BAD LUPUS FLARE UP (SAID EXPERIENCED HIGH TEMPERATURES OF ABOUT 105 DEGREES AND FOLLOWED SEPSIS PROTOCOL) AND THEN NOTICED SEEING REDNESS AND BRUISING RIGHT BELOW NEUROSTIMULATOR. THEY SAID THAT IT LOOKS LIKE A HUGE RED LINE FOLLOWING THE CURVE OF THE NEUROSTIMULATOR. PATIENT SAID THAT THE NEUROSTIMULATOR SITE IS EXTREMELY HOT, SAID TOOK TEMPERATURE AND THE INS SITE WAS 102 DEGREES WHEREAS THE OTHER SIDE OF STOMACH WAS 97 DEGREES. PATIENT ALSO SAID THAT, IN MARCH, THE NEUROSTIMULATOR SITE BECAME VERY SENSITIVE TO ANY TOUCH, VERY PAINFUL, AND THEN THAT SUBSIDED, HOWEVER STARTED UP AGAIN ABOUT FOUR WEEKS AGO AND IS EXTREMELY PAINFUL. PATIENT SAID THAT THE PAIN IS SO SEVERE THAT PATIENT IS TAKING PAIN MEDICATION, OPIOIDS, EVERY SINGLE DAY. PATIENT SAID THEY'RE USED TO THE P

  Patient problems: Alteration in Body Temperature; Bruise/Contusion; Erythema; Hyperresponsive to stimuli; Pain

  MAUDE report 16085969 ↗
• InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). THE DEVICE WAS STILL IN USE.

  Patient problems: Insufficient Information

  MAUDE report 16067498 ↗
• InjuryDec 21, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT PATIENT THE DEVICE WORKED WELL FOR THEM UNTIL RECENTLY WHEN THEY HAD PAIN AND EXPERIENCED SHOCKING SENSATIONS. THE DEVICE IS CURRENTLY TURNED OFF AND THE PATIENT IS WORKING WITH THEIR HCP TO DISCUSS A REVISION

  Patient problems: Electric Shock; Pain

  MAUDE report 16024771 ↗
• MalfunctionDec 1, 2022Break; Electromagnetic Interference; Break; Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION. THE REASON FOR CALL WAS TO PAGE A FIELD REP. THE CALLER INDICATED THAT THE PATIENT WAS IN SURGERY AT THE TIME OF THE CALL AND THE SURGEON DAMAGED ONE OF THE LEAD WIRES WITH ELECTROCAUTERY. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15895737 ↗
• InjuryNov 23, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT PATIENT SAID THE BATTERY IS REALLY LOW, PATIENT SAID THEY THINK IT IS DEAD. PATIENT SAID THEY HAD THEY DEVICE TURNED OFF FOR A COUPLE MONTHS THEN TURNED BACK ON BECAUSE THE DEVICE WAS SHOCKING THEM. THE DEVICE STARTED SHOCKING THE PATIENT IN (B)(6) 2022, THE DEVICE WAS SHOCKING THE PATIENT 3 PLACES - SIDE WAYS ACROSS THEIR MID LINE, DOWN THEIR LEG AND UP INTO THEIR CHEST. ON (B)(6) 2022 THE PATIENT HAS SURGERY TO PUT IN FEEDING TUBES AND THE HCP WANTED TO TURN STIM OFF AND SAID "OH GREAT THE BATTERY IS LOW. ON (B)(6) 2022 THE PATIENT STARTED HAVING STOMACH CONTRACTIONS. PATIENT SAID THEIR STOMACH WAS CONTRACTING EVERY 6-8 SECONDS AND SENDING AIR BUBBLES TROUGH OUT THEIR INTESTINES WHICH WAS VERY PAINFUL. PATIENT SAID THE CONTRACTIONS LASTED ABOUT 24 HOURS. THE HCP IS REPLACING THE PATIENT BATTERY TODAY AND THE PATIENT WOULD LIKE THE DEVICE SENT BACK FOR ANALYSIS. PATIENT SAID THIS WILL BE THEIR 4TH BATTERY IN 8 YEAR.

  Patient problems: Abdominal Pain; Electric Shock; Insufficient Information; Pain

  MAUDE report 15852933 ↗
• InjuryNov 15, 2022High impedance; Connection Problem; Impedance Problem; Insufficient Device Problem Information; High impedance; Connection Problem; Impedance Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP)REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT PRESENTED TODAY TO THE HCP OFFICE WITH AN UPTICK IN HER GASTROPARESIS SYMPTOMS. THE HCP INTERROGATED HER DEVICE AND FOUND THAT HER IMPEDANCE WAS OUT OF RANGE. LEAD 3 WAS GREATER THAN 20,000. HE TURNED OFF LEAD 3 AND MADE THE BATTERY POSITIVE. HE BELIEVES IT IS A SET SCREW ISSUE AND PLANS AT SOME POINT TAKING HER TO THE OPERATING ROOM AND TIGHTENING THE SCREWS. CAUSE IS NOT KNOWN AND ISSUE IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15796985 ↗