ENTERRA® II 37800 (UDI 00763000286798)Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00763000286798), received between Aug 13, 2020 and May 26, 2023 — classified as 54 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (14 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 73 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2023Battery Problem; Battery Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT WAS REPORTED THAT THEY WILL HAVE SURGERY ON JULY 17TH TO REPLACE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010312 ↗
• MalfunctionJan 17, 2023Electromagnetic Interference; Electromagnetic Interference

  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 DAD CALLED AND SAID THE PATIENT WAS WORKING YESTERDAY AND THEY HAD TO GO THROUGH A METAL DETECTOR AND IT SHUT OFF THEIR GASTRIC STIMULATOR. AGENT TOLD THE CALLER TO REACH OUT TO THE DOCTOR AND EXPLAINED TO THE CALLER THAT THE DEVICE CAN'T BE TURNED BACK ON REMOTELY. AGENT SENT A MESSAGE TO THE FIELD REP TO GIVE THE SON A CALL. PATIENT REP CALLED BACK ASKING IF THEY COULD PROVIDE A DIFFERENT PHONE NUMBER TO MEDTRONIC REP AND ASKED WHEN THEY COULD CALL PATIENT BACK. AGENT REVIEWED ROLE OF REP AND OFFERED TO SEND EMAIL BACK TO REP WITH NEW PHONE NUMBER. CALLER SAID THAT THE PATIENT IS IN A REALLY BAD WAY AND THEY HAVE TO TAKE THEM TO THE ER BECAUSE THEY ARE THROWING UP FOOD AND WATER AND THAT IS CAUSING PATIENT TO BE DEHYDRATED. CALLER SAID PATIENT HAS DIABETES.

  Patient problems: Dehydration; Insufficient Information; Vomiting

  MAUDE report 16184420 ↗
• InjuryJan 6, 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  ENTERRA THERAPY WAS PLACED (B)(6) 2021 .PATIENT STATED THAT THEY ¿FELT SOME RELIEF EARLY ON AND THEN NO RELIEF,  AND WENT BACK FOR AN ADJUSTMENT AND THAT HELPED, HAD 2 ADJUSTMENTS SINCE PLACEMENT AND NEEDED ANOTHER, BUT EVERY TIME THEY ARE  SCHEDULED TO GO IN THEY END UP BACK IN THE HOSPITAL FOR WEEKS AT A TIME BECAUSE MY GASTROPARESIS IS SO SEVERE.¿  PT ADVISED TO REACH OUT TO DR. AS SOON AS POSSIBLE FOR FURTHER EVALUATION.

  Patient problems: Paresis

  MAUDE report 16116192 ↗
• InjuryDec 21, 2022Battery Problem; Battery 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 PATIENT SAID THEY HAVE BEEN TRYING TO GET INTO SEE A DOCTOR. PATIENT WAS SCHEDULED FOR SURGERY, BUT THEY ARE WAITING ON INSURANCE APPROVAL. PATIENT SAID THE CURRENT BATTERY IS DEPLETED AND WAS PUT IN ABOUT A YEAR AGO. PATIENT DISCOVERED IT WAS DEPLETED A WEEK AGO. PATIENT SAID THEY HAVE HAD PROBLEMS IN THE PAST AND WERE TOLD TO CALL MEDTRONIC AND REPORT THE PROBLEMS IF THEY HAPPEN. AGENT DID NOT ASK ABOUT THE CIRCUMSTANCES THAT LED TO THE REPORTED ISSUE. PATIENT ASKED IF THERE WAS A RECALL AND AGENT REVIEWED INFORMATION. EMAILED HCP LISTINGS AND MANUAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16024785 ↗
• InjuryDec 11, 2022Premature Discharge of Battery; Insufficient Device Problem Information; Premature Discharge of Battery; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THEIR OLD IPG ONLY LASTED FOR A YEAR WHICH WAS SUPPOSED TO LAST FOR 5 YEARS THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15956331 ↗
• MalfunctionDec 2, 2022Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Compatibility Problem; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Compatibility 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 PATIENT SAID THEY NEED THEIR ENTERRA DEVICE REPLACED (DUE TO NORMAL BATTERY DEPLETION). PATIENT REPORTED THAT WHEN THEIR INTERSTIM SYSTEM WAS FIRST IMPLANTED, IT WAS INTERACTING WITH THEIR ENTERRA DEVICE AND THE ENTERRA DEVICE STARTED SHOCKING THEM. PATIENT STATED THEIR MANAGING HCP ADJUSTED STIM ON THEIR ENTERRA DEVICE TO TURN IT DOWN A LITTLE BIT AND PATIENT NO LONGER FELT SHOCKING. PATIENT SAID TYPICALLY AN ENTERRA DEVICE LASTS THEM A YEAR, BUT BECAUSE IT WAS ABLE TO BE DECREASED IT LASTED THEM 6 MONTHS LONGER. IN (B)(6) OF 2022, THE ENTERRA HCP DETERMINED THE ENTERRA DEVICE WAS DEPLETED. AGENT EMAILED MEDTRONIC REP TO CONTACT PATIENT WITH PHYSICIAN LISTINGS FOR REPLACEMENT GASTRIC STIMULATOR.

  Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15911283 ↗
• InjuryNov 8, 2022Adverse 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 GASTROPARESIS. IT WAS REPORTED THAT THE PATIENT HAD THE DEVICE REMOVED AS PATIENT STATED IT WASN'T WORKING FOR HER IN REGARDS TO REDUCING SYMPTOMS DESPITE ADJUSTING PROGRAMMING.

  Patient problems: Insufficient Information

  MAUDE report 15756098 ↗
• MalfunctionNov 8, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROPARESIS. IT WAS REPORTED THAT THE PATIENT IS REPORTING SHOCKING AT POCKET SITE. THE DEVICE WAS TURNED OFF AND SHOCKING IMPROVED. IMPEDANCE IS AROUND 400. ISSUE WAS RESOLVED.

  Patient problems: Electric Shock

  MAUDE report 15752430 ↗
• InjuryOct 6, 2022Entrapment of Device; Migration or Expulsion of Device; Entrapment of Device; Migration or Expulsion of Device

  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 PATIENTS DEVICE WAS REPLACED DUE TO ERODED GASTRIC STIMULATOR LEADS. THEY SPENT ABOUT 2 HOURS LYSING ADHESIONS AROUND THE ANTERIOR ABDOMINAL WALL. HAD A LOT OF FIBROTIC REACTION AROUND THE LEADS. THE LEADS SEEM TO GO AROUND A FEW LOOPS OF SMALL BOWEL. THE LEADS WERE FOUND AND REMOVED SUCCESSFULLY. ON (B)(6) 2021, AT THEIR FOLLOW UP APPOINTMENT, THE PATIENT WAS NOT WEARING THE BINDER AND THERE WAS SOME FLUID AROUND THE INS. DOCTOR ADVISED PATIENT TO WEAR BINDER TO PREVENT INFECTION. THERE WAS SOME MILD SEROUS DRAINAGE FROM THE UMBILICUS, SO THE DOCTOR OPENED THIS WITH SILVER NITRATE IN ORDER TO PREVENT AN INFECTION FROM DEVELOPING.

  Patient problems: Erosion; Foreign Body In Patient

  MAUDE report 15555216 ↗
• InjurySep 27, 2022Premature Discharge of Battery; Insufficient Device Problem Information; Premature Discharge of Battery; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT  THEIR DEVICE THAT WAS  IMPLANTED (B)(6) 2021) QUIT WORKING AND WAS REPLACED WITH A NEW BATTERY  ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491156 ↗
• InjurySep 1, 2022Entrapment of Device; Migration or Expulsion of Device; Entrapment of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT WAS HAVING AN INCREASE PAIN AND NAUSEA. THE HCP DID AN EXPLORATORY LAP ON (B)(6) 2022 AND FOUND ABDOMINAL ADHESIONS AND TOOK THEM DOWN. SHE ALSO FOUND BOWEL LOOPED AROUND THE LEADS BUT NO BLOCKAGE. SHE THEN REPOSITIONED THE BATTERY. TWO DAYS LATER THE PATIENT JUST WANTED THE DEVICE AND LEADS REMOVED SO THE HCP REMOVED THE IMPLANT. THE ISSUE WAS RESOLVED.

  Patient problems: Nausea; Pain; Scar Tissue

  MAUDE report 15337707 ↗
• MalfunctionAug 5, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING A PATIENT WHO WAS USING AN IMPLANTED NEUROSTIMULATOR (INS) FOR GASTROPARESIS. IT WAS REPORTED THAT THE PATIENT COULD FEEL A LITTLE BIT OF A SHOCK SOMETIMES FROM THEIR DEVICE. THE CALLER STATED THE PATIENT WAS AT THEIR CHECK UP AND THEY ASKED IF THE PATIENT FELT ANY SHOCKING OR TINGLING, AND THE PATIENT STATED "YEAH, EVERY ONCE IN A WHILE." THE CALLER STATED THEY COULDN'T TELL US EXACTLY WHEN IT FIRST HAPPENED BECAUSE THE PATIENT HAD NEVER FUSSED TO THEM ABOUT IT, BUT EVERY ONCE IN A WHILE THE PATIENT WOULD SAY "PUT YOUR HAND HERE," AND THE CALLER COULD FEEL "JUST A LITTLE TINY JERK." THE CALLER STATED THEY THEN TURNED IT DOWN, BUT WHEN THEY DID, IT "WASN'T WORKING EITHER" AND THE PATIENT GOT OTHER SIDE EFFECTS BUT THEY FEEL LIKE THEY FINALLY GOT IT REGULATED TO WHERE IT WAS REALLY WORKING BEST FOR THE PATIENT, TO KEEP THE PATIENT'S BOWELS MOVING AND EVERYTHING GOING, SO THE CALLER STATED IF THE PATIENT GOT A LITTLE SHOCK, THE PATIENT THOUGHT THEY COULD PUT UP WITH THAT VERSUS GOING WITHOUT. THE CALLER STATED THEY DIDN'T WANT TO TURN IT DOWN, BECAUSE THEY'D ALREADY TRIED IT BEFORE AND THEY WERE HAPPY WHERE THE PATIENT WA

  Patient problems: Electric Shock; Insufficient Information

  MAUDE report 15179378 ↗
• InjuryAug 1, 2022Migration or Expulsion of Device; Inappropriate/Inadequate Shock/Stimulation; Migration or Expulsion of Device; Inappropriate/Inadequate Shock/Stimulation

  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  PATIENT SAW DR. ON JULY 15TH, THE BATTERY WAS COMING OUT THROUGH THE SKIN. HCP PACKED THE WOUND AND WANTED TO PUT THE DEVICE INTO AN OSTOMY BAG. CALLER INQUIRED HOW HCP SHOULD CARE FOR THE WOUND. TECHNICAL SERVICES(TS) REVIEWED WITH CALLER THAT HCP NORMALLY WOULD EXPLANT THE NEUROSTIMULATOR AT THIS POINT DUE TO INFECTION CONCERNS, HOWEVER, IT'S UP TO HCP TO ADDRESS THIS ISSUE MEDICALLY. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING.

  Patient problems: Electric Shock; Erosion; Pocket Erosion; Unspecified Tissue Injury

  MAUDE report 15138086 ↗
• InjuryJul 29, 2022Entrapment of Device; Migration or Expulsion of Device; Entrapment of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLAN TED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT PATIENT SHOWED UP TO THE ER AT (B)(6) IN (B)(6), TN WITH ABDOMINAL PAIN. THEY ENDED UP DOING A COLON RESECTION AS THE LEADS HAD ADHERED TO HER COLON. CAUSE WAS REPORTED TO BE LEAD ADHESION TO COLON. HCP WAS ABLE TO REMOVE THE ADHESION AND FREE THE LEADS UP WITHIN THE ABDOMEN ON (B)(6) 2022. THE ISSUE WAS CONFIRMED RESOLVED.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Inflammation

  MAUDE report 15129001 ↗
• MalfunctionJul 11, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROPARESIS. IT WAS REPORTED THAT THE PATIENT REPORTED EVERY SO OFTEN IT WILL SHOCK THEM IF THEY LAY WRONG. PATIENT STATED IT IS NOT A CONTINUOUS ISSUE IT ONLY OCCURS ONCE EVERY COUPLE OF MONTHS AND AS SOON AS THEY MOVE IT STOPS. IT OCCURS PARTICULAR WHEN PATIENT IS LAYING ON THEIR SIDE. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. NO FURTHER COMPLICATIONS WERE REPORTED AT THIS TIME.

  Patient problems: Electric Shock

  MAUDE report 14982086 ↗
• MalfunctionJun 22, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT SERIAL NUMBER (B)(4) AS IMPLANTED AFTER ITS USE BEFORE DATE. IMPLANT DATE (B)(6) 2022, USE BEFORE DATE 01/28/2022. BEGAN PROCESSING ON (B)(6) 2022 AND THEY ARE  CURRENTLY RESEARCHING WHETHER (B)(4) WAS IMPLANTED AFTER USE BEFORE DATE OR IF INFORMATION WAS PROVIDED IN ERROR. FOLLOW-UP WILL BE PROVIDED UPON RESEARCH COMPLETION. PER MDT REP, THEY DID NOT HAVE ANY EXPIRED OR SHORT DATED INVENTORY ON THE SHELF SO THIS IS IMPOSSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14776540 ↗
• InjuryJun 13, 2022Adverse 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 GASTRIC STIMULATION AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A BATTERY EROSION/INFECTED POCKET. THEY CLIPPED THE LEADS AND REMOVED THE BATTERY. PORTION OF THE LEADS LEFT BEHIND IN THE PATIENT. THE ISSUE WAS RESOLVED.

  Patient problems: Device Embedded In Tissue or Plaque; Pocket Erosion; Unspecified Infection

  MAUDE report 14676321 ↗
• InjuryJun 6, 2022Adverse 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 GASTRIC STIMULATION. IT WAS REPORTED THAT THE PATIENT SAW THE HEALTHCARE PROVIDER (HCP) ON (B)(6) 2022 AND HAD NAUSEA AND LOWER ABDOMINAL PAIN. THE HEALTHCARE PROVIDER (HCP) REFERRED TO ANOTHER HCP TO GET A BATTERY REPLACEMENT. THE PATIENT HAS POCKET PAIN FROM THE BATTERY. A REVISION HAS BEEN SCHEDULED.

  Patient problems: Nausea; Pain

  MAUDE report 14601638 ↗
• InjuryJun 5, 2022Adverse 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 GASTRIC STIMULATION. IT WAS REPORTED THAT  PATIENT ADMITTED TO HOSPITAL FOR NAUSEA, VOMITING, AND SEVERE ABDOMINAL PAIN. CALLER ALSO MENTIONED PATIENT HAD HEMATEMESIS (VOMITING OF BLOOD).CALLER REQUESTED INS BE CHECKED.

  Patient problems: Abdominal Pain; Nausea; Vomiting

  MAUDE report 14599571 ↗
• MalfunctionMay 25, 2022Low impedance; Battery Problem; Low impedance; Battery Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT  THE HCP REPORTED SEEING THE PATIENT TODAY AND UPON INTERROGATION THE INS IS AT EOS. HCP ALSO MENTIONED LOW IMPEDANCES. WE DISCUSSED INS MOST LIKELY HAS A SHORT CIRCUIT DEPLETING THE INS RAPIDLY. THE HCP INDICATED ABOUT 2 WEEKS AGO PATIENT HAD RETURN OF SYMPTOMS, NAUSEA AND VOMITING. THE HCP REQUESTED REP INFORMATION - REDIRECTED TO NAS FOR REP PAGEOUT. NO FURTHER COMPLICATIONS WERE REPORTED AT THIS TIME.

  Patient problems: Nausea; Vomiting

  MAUDE report 14493283 ↗
• MalfunctionMay 9, 2022Electromagnetic Compatibility Problem; Electromagnetic Compatibility Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT PATIENT'S ENTERRA IS AFFECTING THEIR EKG RESULTS AND CARDIAC DEVICE (UNKNOWN IF PACEMAKER OR ICD). TSS REVIEWED IFP INFORMATION AND REP IS GOING TO SEE THE EP DOCTOR TO DETERMINE IF IT IS THE ENTERRA OR SOMETHING ELSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14341755 ↗
• InjuryApr 29, 2022Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT PER FAX RECEIVED ON 4/26/2022, OP REPORT INDICATIONS SAYS ONE OF THE LEADS FRACTURED AND THE SYSTEM WAS NONFUNCTIONAL. THE PROCEDURE DATE WAS ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14254597 ↗
• InjuryApr 18, 2022Premature Discharge of Battery; Intermittent Continuity; Battery Problem; Premature Discharge of Battery; Intermittent Continuity; Battery Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION. IT WAS REPORTED THAT THE REASON FOR THE CALL WAS THAT THE PATIENT REPORTED THEY JUST FOUND OUT THEIR IMPLANT BATTERY WAS DEAD AFTER ONLY 13 MONTHS. THE PATIENT REPORTED THIS IMPLANT WAS THEIR SIXTH ONE, AND THAT EACH IMPLANT LASTED ABOUT TWO YEARS UNTIL THEY DEPLETED NORMALLY DUE TO THE HIGH SETTINGS THE PATIENT USED, HOWEVER, THIS IMPLANT WAS AT A SLIGHTLY LOWER SETTING THAN THE OTHER IMPLANTS. THE PATIENT REPORTED THEIR TYPICAL SYMPTOMS WERE THAT THEY WOULD HAVE INTERMITTENT NAUSEA ONCE OR TWICE A MONTH THAT WOULD RESOLVE ON ITS OWN, HOWEVER, ON (B)(6) 2021, THEY RECEIVED THEIR FIRST COVID VACCINATION AND AFTER THAT SHOT, THEY COULD TELL THEY STARTED TO EXPERIENCE THEIR SYMPTOMS A LITTLE BIT MORE. THE PATIENT THEN WENT TO GET THEIR SECOND COVID VACCINATION ON (B)(6) 2022, AND THAT WAS WHEN THEIR SYMPTOMS REALLY STARTED TO GET WORSE AND THEY WERE PUT ON A MEDICATION. THE PATIENT STATED THEY TYPICALLY WEIGHED (B)(6) POUNDS, HOWEVER, THEY LOST (B)(6) POUNDS FROM (B)(6), SO THEY WENT TO SEE THEIR MANAGING HEALTH CARE PROVIDER (HCP) WHO INCREASED THE SETTING AT

  Patient problems: Malaise; Nausea; Weight Changes

  MAUDE report 14135642 ↗
• InjuryMar 15, 2022High impedance; Insufficient Device Problem Information; High impedance; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THE PA (PHYSICIAN ASSISTANT) FOR THE DOCTOR INTERROGATED THE PATIENT'S DEVICE AND FOUND IT TO BE OUT OF RANGE. C<(>&<)>2 WAS 362 (OHMS), C<(>&<)>3 WAS 857 (OHMS), AND 2<(>&<)>3 WAS 1098 (OHMS). THEY TURNED UP THE VOLTAGE ON THE PATIENT FROM 6 TO 7 VOLTS, AND REFERRED THE PATIENT TO THE DOCTOR WHO DID THEIR SURGERY TO DO AN ESOPHAGOGASTRODUODENOSCOPY (EGD) AND TO GET AN ANTEROPOSTERIOR (A/P) X-RAY. IT WAS UNKNOWN IF THERE WERE ANY ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE IMPEDANCE ISSUE. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. NO SURGICAL INTERVENTION OCCURRED, AND NONE WAS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13765334 ↗
• InjuryFeb 21, 2022High impedance; Insufficient Device Problem Information; High impedance; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT WAS BEING SEEN BY THE PA AT DR. KEN KOCH'S OFFICE FOR A DEVICE CHECK AND FOUND THAT THE PATIENT'S IMPEDANCE WAS OUT OF RANGE (>20,000). THE PA TURNED OFF LEAD 2 AND MADE LEAD 3 NEGATIVE AND THE CAN POSITIVE. THEY WERE REFERRING THE PATIENT OUT TO DR. FERNANDEZ TO TIGHTEN THE SET SCREW WHICH IS BELIEVED TO BE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13569237 ↗