Enterra® II 37800 (UDI 00643169360686)Recalls & reported problems

Summary

The FDA's MAUDE database contains 248 adverse event reports that list this exact device (DI 00643169360686), received between Nov 8, 2016 and Sep 25, 2023 — classified as 1 death, 162 injuries, 85 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (55 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 248 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 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 SAID THAT FOR GASTRIC STIMULATOR THE LEADS HAVE BEEN COMPROMISED AND IS IN THE HOSPITAL. PATIENT SAID THAT PHYSICIAN WOULD LIKE TO SPEAK TO SOMEONE ABOUT PATIENT'S IMPLANT. TRANSFERRED TO ENTERRA MEDICAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17809258 ↗
• MalfunctionJul 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 INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) . THE REASON FOR CALL WAS CALLER REPORTS THAT THEIR DEVICE NOT WORKING AS WELL FOR THE PAST FEW MONTHS AND THEY ARE BACK TO THEIR "OLD SELF" AND THROWING UP EVERY DAY. THE CALLER NOTED THAT THEY ARE STRESSED AND ARE ALSO HAVING MENTAL HEALTH PROBLEMS AND GETTING ELECTRIC SHOCK THERAPY ON THE BRAIN FOR TREATMENT, DUE TO THIS TREATMENT THEY HAVE PROBLEMS WITH MEMORY. THEY COULD NOT REMEMBER WHO THEIR DR WAS AND ASKED THAT WE PROVIDE THAT INFO TO THEM. REVIEWED LONGEVITY, REVIEWED HCP THAT WE SHOW ON FILE (IMAN GHADERI), REVIEWED ELECTRIC SHOCK THERAPY COMPATIBILITY - THE CALLER NOTED THAT THEY WILL DISCUSS THE IMPLANT AND ELECTRIC SHOCK THERAPY COMPATIBILITY WITH BOTH MANAGING HCP FOR THE DEVICE AND THE PROVIDER OF THE ELECTRIC SHOCK THERAPY. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. REDIRECTED CALLER: PATIENT'S HCP.

  Patient problems: Distress

  MAUDE report 17418158 ↗
• InjuryJun 13, 2023Device Difficult to Program or Calibrate; Insufficient Device Problem Information; Device Difficult to Program or Calibrate; 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  THE (B)(6) 2016 EXPLANTED AND CLINICAL NOTE SHOWED THE PATIENT HAD A DIFFICULT TIME WITH IT AND  PATIENT  WAS NOT ABLE TO GET IT PROGRAMMED  SEE RELATED PE: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17121065 ↗
• InjuryMay 5, 2023Inappropriate/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 SHOCKING SENSATION WITH THE DEVICE.

  Patient problems: Electric Shock; Insufficient Information

  MAUDE report 16882585 ↗
• MalfunctionApr 24, 2023Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information; Inappropriate/Inadequate Shock/Stimulation; 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 THEY WERE EXPERIENCING "SHOCKING" SENSATIONS WHILE HAVING DEVICE.  AND THE DEVICE DID NOT WORK.

  Patient problems: Electric Shock

  MAUDE report 16797668 ↗
• InjuryMar 2, 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. IT WAS REPORTED THAT PER HCP (B)(6) AT DR (B)(6), EXISTING DSC WERE REMOVED DUE TO INFECTION AND REPLACED ON (B)(6) 2023.

  Patient problems: Unspecified Infection

  MAUDE report 16473090 ↗
• MalfunctionDec 9, 2022Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Compatibility Problem; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Compatibility Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR THERAPY AND GASTRIC STIMULATION. IT WAS REPORTED THAT THE PATIENT STATED THEY MOVED TO A NEW HOME AND THE ELECTRICITY IN THE HOUSE IS NOT GROUNDED PROPERLY AND PATIENT KEEPS GETTING LITTLE ZAPS. THE ZAPS STARTED OUT DULL BUT THE LONGER THEY WERE IN THE HOME THE MORE INTENSE THE BUZZING SENSATION AND ELECTRIC SHOCK SENSATION WAS. IT WAS MOST INTENSE WHEN PATIENT WAS NEXT TO THE WASHER AND DRYER. PATIENT WANTED TO KNOW IF THERE WERE ANY PRECAUTIONS THEY COULD TAKE WITH REGARDS TO THE UNGROUNDED HOME APPLIANCES AND THEIR ENTERRA SYSTEM. CONSULTED WITH TECH SERVICES AND REVIEWED CONSIDERATIONS WITH PATIENT REGARDING USE OF UNGROUNDED APPLIANCES.

  Patient problems: Electric Shock

  MAUDE report 15954836 ↗
• InjuryNov 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  2022-OCT-31 RTG0367841 RTG SNOW RTG0367872 (CON): INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEU ROSTIMULATOR (INS) FOR GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT REPORTED THEIR LEADS WERE REPLACED ON (B)(6) 2016 BECAUSE IT HADN'T BEEN WORKING PATIENT SERVICES REVIEWED THAT THEIR CURRENT INS WAS PLACED IN 2015 AND THE PATIENT REPORTED THAT THEIR WHOLE IMPLANT HADN'T BEEN WORKING NOW FOR A COUPLE OF YEARS.  THE PATIENT STATED THEY WERE GOING TO SEE DR. AT THE END OF THE MONTH REGARDING THEIR IMPLANTED SYSTEM. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED THE PATIENT WAS CURRENTLY HOSPITALIZED AND NEEDED AN MRI. PATIENT SERVICES ASKED IF THE REASON THE PATIENT WAS HOSPITALIZED WAS DUE TO THE IMPLANT NOT WORKING AND THE PATIENT STATED "NO," THAT THEY WERE HOSPITALIZED BECAUSE THEY'D BEEN HAVING LOW BACK PAIN AS WELL AS PAIN IN THEIR RIGHT HIP/LEG AREA.

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

  MAUDE report 15737517 ↗
• InjurySep 29, 2022Malposition of Device; Insufficient Device Problem Information; Malposition of Device; Insufficient Device Problem Information

  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 PER OP NOTES RECEIVED (B)(6) 2022, IT WAS MENTIONED PTS LEADS WERE REPLACED BACK IN 2016 DUE TO A MALPOSITIONED LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15502850 ↗
• MalfunctionSep 15, 2022Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Insufficient Device Problem Information; Inappropriate/Inadequate Shock/Stimulation; Battery Problem; 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 THEY ARE A HAPPY CUSTOMER AND THE DEVICE HAS CHANGED THEIR LIFE BUT SOMETIMES THE DEVICE "ZAPS" THEM, THE BATTERY DIES OR IT MAY NEED TO BE REPLACED, PATIENT WOULD LIKE TO BE ABLE TO GET THESE THINGS DONE W/ OUT THE 3 HOUR TRIP. PATIENT SAID THEY CONTACTED A CLOSER DOCTOR WHO CAN CHECK THE DEVICE BUT NOT REPLACE IT. PATIENT SAID BECAUSE THEY WOULD BE A NEW PATIENT THE HCP CAN'T SEE THE PATIENT TILL MARCH WHICH THE PATIENT FEELS IS RIDICULOUS WHEN YOU ARE THROWING UP EVERY DAY. PATIENT SAID THEY HAVE A FEELING THE DEVICE ISN'T WORKING. PATIENT SAID ABOUT A MONTH AND A HALF AGO THEY STARTED THROWING UP MORE. PATIENT THOUGHT IT WAS THE FIREBALL SHOT THEY HAD W/ THEIR BEER BUT NOT THEY THINK THE INS MIGHT NEED TO BE REPLACED. PATIENT SAID THEY TAKE PILLS THAT ARE GIVEN TO CANCER PATIENTS TO HELP W/ NAUSEA WHICH DO HELP BUT THEY CAN'T TAKE THEM FOR EVER. SENT HCP LISTINGS.

  Patient problems: Electric Shock; Vomiting

  MAUDE report 15427754 ↗
• InjuryJun 8, 2022Break; Migration or Expulsion of Device; Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information; Break; Migration or Expulsion of Device; Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information

  2022-JUN-03 (B)(4) (CON): INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION. IT WAS REPORTED THAT, NOTHING'S BEEN WORKING RIGHT, THEY THOUGHT MAYBE PT HAD A MECHANICAL BOWEL OBSTRUCTION. PT SAID THEY ARE FEELING DIFFERENT THINGS WITH THEIR GASTRIC PACEMAKER. PATIENT THINKS THE  (LEADS) GOT TWISTED ON THE LEFT SIDE OF THEIR COLON AND THE RIGHT SIDE OF THE PACEMAKER (LEADS) GOT TWISTED THEY CAN'T SEE THE LEAD THEY ARE FEELING DIFFERENT THINGS WITH THEIR GASTRIC PACEMAKER.  EVERYTHING IS FINE BUT PT THINKS THE LEFT SIDE OF THEIR COLON AND THE RIGHT SIDE OF PACEMAKER (LEADS) GOT TWISTED THEY CAN'T SEE THE LEAD, ALL THEY CAN SEE IS STOOL (IN THE CT). PT SAID: ONE GIRL COULD SEE THE PACEMAKER, BUT PT FEELS LIKE IT SHIFTED. PT SAID THEY THINK WHEN THEY THREW UP SO MUCH THE LEADS CAME OUT AND ARE OBSTRUCTING AROUND THE COLON. PT SAID SINCE (B)(6) 2021, THEY HAVE BEEN GETTING SHOCKEDGETTING SHOCKED, GETTING PAIN ON THE RIGHT SIDE LIKE A WIRE IS TRYING TO COME THROUGH THEIR SKIN. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PT SAID THEY HAVE BEEN DOING ALL THESE TESTS WITH THEIR

  Patient problems: Electric Shock; Insufficient Information; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 14638170 ↗
• InjuryJun 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR ENTERRA STIMULATION IT WAS REPORTED THAT THE BATTERY WAS NO GOOD AND PATIENT WAS EXPERIENCING PRETTY SEVERE SYMPTOMS AND A LOT OF PAIN. PATIENT'S SETTINGS ARE SET SMAT 3 WITH THE NORMAL BEING. WITH THE SEVERITY THEY ENCOUNTER WITH GASTROPARESIS

  Patient problems: Pain

  MAUDE report 14599610 ↗
• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM AN HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT MDT REP REPORTS THE DOCTOR IS GOING TO DO A POCKET REVISION AND MOVE THE INS, BECAUSE THE PATIENT (PT) IS HAVING PAIN AT THE POCKET SITE.

  Patient problems: Pain

  MAUDE report 14436637 ↗
• MalfunctionMay 11, 2022Intermittent Continuity; Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Intermittent Continuity; Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation; Battery Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN GASTRIC INDICATIONS FOR USE. IT WAS REPORTED THAT THE REASON FOR THE CALL WAS THAT THE BATTERY WAS DEAD, BUT FOR THE LAST COUPLE MONTHS, THE PATIENT HAD FELT THE DEVICE "KICK ON" AND "SHOCK" THEM. THEY SAID THEY WENT TO THE EMERGENCY ROOM (ER) WHEN THIS FIRST HAPPENED IN JANUARY. THE PATIENT TOLD THE HEALTHCARE PROVIDER ABOUT IT. ADVERSE EVENTS WERE REVIEWED.  THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Electric Shock

  MAUDE report 14364346 ↗
• InjuryApr 13, 2022Break; Break

  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 DURING A BATTERY CHANGE ON (B)(6) 2022, THE HEALTHCARE PROFESSIONAL (HCP) STATED THAT THE LEAD BROKE WHILE THEY WERE PUTTING THE NEW BATTERY BACK INTO THE PATIENT. THE DOCTOR CLOSED THE POCKET AND PLANS ON GOING BACK AND REPLACING THE BROKEN LEAD. IT HAS NOT BEEN SCHEDULED YET. THE DEVICE HAD BEEN TURNED OFF AND THE ISSUE WAS NOT YET RESOLVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14106326 ↗
• InjuryApr 11, 2022Insufficient Device Problem Information; 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 IT HASN'T BEEN ON FOR OVER TWO YEARS AND PATIENT IS  DOING FINE. A PYLOROMYOTOMY WAS DONE A FEW YEARS AGO AND THAT SEEMS TO BE WORKING. THEY THINK THE BATTERY CAUSES PAIN AND THEY ALSO DON'T LIKE THE IDEA OF USELESS WIRES IN THE PATIENT'S GUTS. THE DEVICE WILL BE REMOVED ON (B)(6) 2022.

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

  MAUDE report 14073654 ↗
• InjuryFeb 24, 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 BY THE HOSPITAL HCP THAT THE PATIENT WAS ADMITTED FOR SEVERE GASTROPARESIS THAT STARTED APPROXIMATELY LAST WEEK. THE PATIENT IS CURRENTLY HOSPITALIZED AND PRIOR TO RELEASING PATIENT THEY REQUESTED THE INS BE CHECKED.

  Patient problems: Paresis

  MAUDE report 13591843 ↗
• InjuryFeb 4, 2022Positioning Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THE REASON FOR THE CALL WAS TO REPORT THAT WITH THEIR FIRST IMPLANT, WITHIN SIX MONTHS AFTER THE DATE OF IMPLANT, THE INS WAS POKING OUT AND HURT. THEY SAID THE POCKET NEVER FORMED PROPERLY. THE PATIENT SAID THEY USED A HERNIA SUPPORT BAND, WHICH DID NOT HELP. THEY SAID THE SURGEON HAD TO SWITCH IT DOWN, AND THE REVISION RESOLVED THE ISSUE. NO FURTHER ACTION WAS TAKEN BY THE MANUFACTURER HELP LINE.

  Patient problems: Impaired Healing; Insufficient Information; Pain; Pocket Erosion

  MAUDE report 13457204 ↗
• InjuryDec 16, 2021Insufficient Device Problem Information; 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 PATIENT MENTIONED THAT HIS BATTERY HAS BEEN REPLACED SINCE THE OLD BATTERY STOP WORKING. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13020462 ↗
• MalfunctionSep 23, 2021Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION. IT WAS REPORTED WHEN THEY SAW THEIR DOCTOR A MONTH AGO, THEIR DOCTOR TOLD THEM THAT WHEN THEY HAD THEIR NEXT VISIT IN 3 MONTHS THE GASTRIC PACEMAKER WILL BE COMPLETELY DEAD. THE PT SAID THEY THOUGHT THE INS BATTERY SHOULD LAST 10 YEARS. THE PT SAID THEY HAVE NOT HAD ANY ISSUES AND ASKED IF LEAVING A DEAD DEVICE INSIDE OF THEM WOULD CAUSE ISSUES. PATIENT SERVICES REVIEWED INFORMATION. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED THAT THEY ALSO HAVE A RARE ARTERY DISEASE THAT MIMICS GASTROPARESIS CALLED CELIAC ARTERY COMPRESSION SYNDROME. THE PT SAID THEY HAD BYPASS SURGERY FOR THE ARTERY AND THE DOCTOR TELLS THEM THEY THINK THE PT WILL DO FINE, BECAUSE THAT HAS BEEN CORRECTED AND WON'T NEED THE PACEMAKER. THE DOCTOR WANTS THEM TO TRY WITHOUT A PACEMAKER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519690 ↗
• MalfunctionSep 21, 2021Intermittent Continuity; Energy Output Problem; Therapy Delivered to Incorrect Body Area; Intermittent Continuity; Energy Output Problem; Therapy Delivered to Incorrect Body Area

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL FOR ABOUT 4 YEARS. THE PATIENT WAS UP TO THEY THINKS (B)(6) POUNDS. IN (B)(6) 2020 IT SEEMED TO HAVE STOPPED WORKING, AND THEY WENT TO THE DOCTOR AND THEY RECALIBRATED IT 3-4 TIMES. THEY WENT BACK TO THE DOCTOR A COUPLE MORE TIMES TO THE SURGEON.  THEY THEN WENT TO A NEW DOCTOR AND THAT DOCTOR CALIBRATED IT ONCE. THE PATIENT HAS BEEN ABLE TO SEE A FLUTTER IN HER STOMACH SINCE THEY GOT THE IMPLANT. IF SHE PUTS A QUARTER ON THEIR STOMACH THEIR CAN SEE IT MOVE OR FLUTTER EVERY FOUR MINUTES SINCE THE RETURN OF SYMPTOMS, AND THEN THE FLUTTERING STOPPED AND JUST HAPPENED ONCE AND A WHILE. PRIOR THE PATIENT COULD SEE THEIR STOMACH MOVE MORE FREQUENTLY. THE SECOND DOCTOR SAW THE FLUTTER OR MOVING OF THEIR STOMACH AND SAID IT WAS NOT SUPPOSED TO BE ABLE TO FEEL THE STIMULATION OR SEE THEIR STOMACH MOVING THAT SOMETHING WAS WRONG. CALLER WANTED TO KNOW IF THAT WAS TRUE BECAUSE THEY ARE GETTING CONFLICTING ANSWERS. PATIENT HAS LOST (B)(6) POUNDS IN THE LAST SIX MONTHS AND WAS DOWN TO (B)(6)

  Patient problems: Insufficient Information; Undesired Nerve Stimulation

  MAUDE report 12510079 ↗
• InjurySep 14, 2021Electromagnetic Interference; Failure to Deliver Energy; Battery Problem; Insufficient Device Problem Information; Electromagnetic Interference; Failure to Deliver Energy; Battery Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION AND GAST ROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THEY STATED THEY TURNED OFF PATIENT'S INS WHILE IN THE HOSPITAL. THE PATIENT REPORTED WHEN IN THE HOSPITAL, THE PATIENT HAD A BUNCH OF TESTS COMPLETED AND STATED THEY HAD AN MRI SCAN. THE PATIENT STATED THEY WENT TO THE ER FIRST AND STATED THIS ALL STARTED ON (B)(6). PT STATED THEY DIDN'T KNOW THEIR INS WAS TURNED OFF WHILE PT WAS IN THE HOSPITAL UNTIL TWO DAYS LATER AND STATED THEY SAW THE HEALTHCARE PROVIDER (HCP) THAT INFORMED PT THAT THEIR INS WAS TURNED OFF AND STATED HCP "RESET IT". PT STATED AT THAT TIME THEY WERE TOLD THEIR INS BATTERY IS LOW AND STATED THE SOONEST THEY CAN GET IN FOR SURGERY IS (B)(6) DUE TO NO REP AVAILABILITY PRIOR TO THEM. PT REPORTED THEY CONTACTED THE HCP YESTERDAY AND STATED THEY THINK INS NEEDS TO BE "TWEAKED" OR TURNED UP OR INS BATTERY IS ALREADY DEAD BECAUSE PT CAN TELL INS IS NOT WORKING. PT STATED IT'S EITHER DEAD OR BARELY WORKING. PT STATED THEY DON'T KNOW WHAT CONDITION THEY WILL BE IN OR IF THEY WILL BE ALIVE IF PT NEEDS TO WAIT FOR (B)(6). PT STATED THEY NEED T

  Patient problems: Malaise; Nausea; Vomiting

  MAUDE report 12469374 ↗
• InjuryAug 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THAT THEY SPOKE WITH HCP (B)(6) THAT IS WILLING TO REMOVE ALL THREE ENTERRA II GASTRIC STIMULATORS THAT PT STATED THEY STILL HAVE IMPLANTED. PT STATED THE "THIRD ONE IS IN MY BICEP" (AGENT NOT CLEAR WHAT PT WAS REFERRING TO BY THIS STATEMENT). PT STATED THEY ALSO HAVE "A BUNCH OF CABLES" AND STATED DR. (B)(6) IS WILLING TO TAKE OUT ALL OF THE DEVICES AND CABLES BUT STATED DR. (B)(6) WON'T IMPLANT ANOTHER ENTERRA DEVICE. PT STATED THAT GASTROPARESIS IS A FATAL DISEASE AND PT STATED THEY WILL DIE WITHOUT ANOTHER DEVICE. PT STATED THE VOMIT EVERY TIME THEY EAT THE FOOD COMES RIGHT BACK UP. PT THEN STATED THEY WILL "DIE ANYWAYS". PT STATED THEIR LIFE IS IN DANGER AND STATED IF THEY DIE THEY ARE COMING FOR THEIR DRS IN COURT IN A COFFIN. PT STATED THEY HAVE TALKED TO ALL DRS ON THE PHYSICIAN LISTING PT RECEIVED AND DR. (B)(6) IS THE ONLY DR THAT WILL REMOVE THE DEVICES. REDIRECTED PT TO INSURANCE/PCP FOR MORE HCP INFORMATION. REVIEWED ROLE OF PS AND REDIRECTED PT TO HCP TO DISCUSS MEDICAL CONCERNS. PT THEN DISCONNECTED CALL SO AGENT WAS UNABLE TO COLLECT ANY FURTHER EVENT INFORMATION. ON 2021 (B)(6) THE PATIENT CALLED B

  Patient problems: Adhesion(s); Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12368728 ↗
• InjuryJun 14, 2021Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION. IT WAS REPORTED THAT THE PATIENT'S GASTRIC INS WAS REMOVED BECAUSE IT DIED AND THE WIRES GOT BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Scar Tissue

  MAUDE report 11991723 ↗
• InjuryApr 16, 2021Unstable; Malposition of Device; Unstable; Malposition of Device

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT INS LONGEVITY INFORMATION WAS RECEIVED FROM A PATIENT. THE REASON FOR THE CALL WAS THAT THE PATIENT'S PREVIOUS INS WAS "LOPSIDED," SO THEY HAD A REVISION SURGERY TO MAKE THE INS DEEPER. THE INS FELT LIKE IT WAS FALLING OUT OF THEIR STOMACH. THE PATIENT STATED THEY THOUGHT THIS OCCURRED IN "I WANT TO SAY 2016". THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED THEIR PREVIOUS INS WAS REPLACED. THEY CONFIRMED THIS WAS DUE TO NORMAL BATTERY DEPLETION. THEY ALSO STATED THIS INS ONLY LASTED FIVE YEARS AND INQUIRED IF THAT WAS NORMAL. THE PATIENT LATER CLARIFIED THAT THEY THOUGHT THIS WAS NORMAL BECAUSE THEY HAD THERAPY SET AT A "PRETTY HIGH NUMBER".

  Patient problems: Abdominal Pain; Inflammation; Insufficient Information

  MAUDE report 11678673 ↗