ENTERRA® 3116Recalls & reported problems

Summary

The FDA's MAUDE database contains 179 adverse event reports that list this exact device (DI 00643169174993), received between Oct 20, 2014 and Nov 16, 2023 — classified as 115 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (46 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 179 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2023Noise, Audible; Noise, Audible

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/ PELVIC FLOOR. THE REASON FOR CALL WAS PATIENT SAID THEY ARE WONDERING IF THE INS MAKES A NOISE OR AN INDICATION WHEN THE BATTERY IS LOW BECAUSE TODAY, THE INS MADE A WEIRD LITTLE SOUND. PATIENT SAID AT FIRST THEY THOUGHT IT WAS GAS, BUT PATIENT SAID IT SOUNDED LIKE A FAINT MOTOR GOING ON. PATIENT SAID THEY'VE ONLY HEARD THE NOISE ONCE TODAY. REDIRECTED TO HCP TO DISCUSS POSSIBILITY OF LOW BATTERY AND RECOMMENDED PATIENT MONITOR ANY CHANGES TO DISCUSS AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18150139 ↗
• InjuryMar 17, 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 THEY DID NOT HAVE EFFECT. ADDITIONAL INFORMATION WAS RECEIVED ON 2022-DEC-15. THE PATIENT REPORTED THEY WERE DIAGNOSED IN 2011. THEY TRIED THE GASTRIC DEVICE PUT IN BUT SURGEON NICKED THEIR BOWELS AND THEY WENT INTO SEPTIC SHOCK. THEY WERE IN A COMA FOR A WEEK, TOTAL 1 MONTH IN HOSPITAL AND THEN REHAB FACILITY. IT HAS BEEN A NIGHTMARE FOR 11 YRS NOW AND SOME DAYS THE PATIENT DOESN'T WANT TO BE ALIVE.

  Patient problems: Coma; Insufficient Information; Sepsis; Suicidal Ideation

  MAUDE report 16567714 ↗
• MalfunctionJan 31, 2023Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; 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 PATIENT HAS ONE [GASTRIC STIMULATOR] IMPLANTED, AND THAT IT HAS BEEN DEAD FOR 3-4 YEARS, BATTERY LIFE WAS A YEAR.  PATIENT ALSO REPORTED IT IS SO PAINFUL. THEY STATED THAT EVERY TIME THEY SWALLOW, IT STARTS PULLING. THEY ALSO SAID IT DIDN¿T HELP AT ALL.

  Patient problems: Insufficient Information; Pain

  MAUDE report 16271817 ↗
• InjuryJan 27, 2023Break; Difficult to Remove; Break; Difficult to Remove

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION. IT WAS REPORTED THAT WHEN THE PATIENT WAS SUPPOSED TO GET A BATTERY REPLACEMENT IN NOVEMBER AND THEY FOUND OUT THAT IT WASN'T WORKING APPROPRIATELY AND SAID THEY THINK IT WAS PROBABLY FROM THE MACHINE (LATER CLARIFIED THAT THE MACHINE WASN'T HELPING THEIR SYMPTOMS). PATIENT SAID THAT WHEN THEY "GOT IN THERE" THE RECEPTORS THAT GO TO THE STOMACH WERE EMBEDDED, IT WENT THROUGH THE LINING, IT WAS ENCAPSULATED AND THEY THOUGHT IT WAS INFECTED. PATIENT SAID IT HAD A LOT OF WHITE CELLS BUT THERE WERE NO GERMS AND AT THE TIME HE FOUND THAT HE CUT THE LEAD WIRES AND CUT THE REST OF IT (FULL SYSTEM) OUT. PATIENT SAID THEY DID AN "EDG" AND 2-3 WEEKS LATER THEY WENT BACK TO SEE THE HCP TO RETRIEVE THE LEAD WIRES AND THE HEALTHCARE PROVIDER (HCP) COULD ONLY GET ONE OUT BECAUSE THE OTHER ONE WAS SO IMBEDDED AND SO INCAPSULATED AND THE DOCTOR COULDN'T GET IT OUT. PATIENT SAID THEN THEY SCHEDULED THE REPLACEMENT SURGERY IN (B)(6) 2023 AND THE HCP SAID THEY WOULD TRY TO GET THE OTHER WIRE "WHILE WE ARE IN THERE" AND THE HCP WAS ABLE TO PULL THE OLD WIRE OUT AND THEN FOUND A

  Patient problems: Hernia; Internal Organ Perforation; Unspecified Infection

  MAUDE report 16252638 ↗
• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). THE HCP REPORTED THAT ON (B)(6) 2022 THE PATIENT PRESENTED TO ER - PROTRUSION OF BATTERY THROUGH SKIN - AND COPIOUS AMOUNTS OF SEROUS FLUID LEAKING FROM SITE - NO FEVER, CHILLS. ON (B)(6) 2022 BATTERY REMOVED - LEADS REMOVED - BATTERY TO BE REPLACED 4-6 WEEKS POST-OP. IT WAS NOTED THAT THE PATIENT WAS IMPLANTED TO TREAT GASTROPARESIS.

  Patient problems: Fluid Discharge; Pocket Erosion; Swelling/ Edema

  MAUDE report 16242531 ↗
• InjuryDec 9, 2022Adverse 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 WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR GASTRIC STIMULATION.  IT WAS REPORTED IT WAS REPORTED THAT  THE PATIENT'S GASTRIC STIM WAS REMOVED ON (B)(6) 2022  PATIENT UNSURE IF ENTIRE SYSTEM, INCLUDING THE LEADS, WAS REMOVED. THE PATIENT ALSO SAID THAT THE DEVICE HAD BEEN TURNED OFF FOR A LONG TIME PRIOR TO THE EXPLANT BECAUSE IT GAVE THEM DUMPING SYNDROME WHICH CAUSED HIM TO POOP ALL THE TIME. THEY ENDED UP REMOVING THE DEVICE BECAUSE IT WAS GIVING HIM TROUBLES.

  Patient problems: Incontinence; Insufficient Information

  MAUDE report 15954429 ↗
• InjuryNov 14, 2022High impedance; Energy Output Problem; Battery Problem; Electromagnetic Compatibility Problem; High impedance; Energy Output Problem; Battery Problem; Electromagnetic Compatibility Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THE CALLER STATED THAT THE PATIENT HAS HAD A RETURN OF SYMPTOMS AND THE NURSE PRACTITIONER (NP) NOTICED, UPON INTERROGATION TODAY, A FEW THINGS WERE OUT OF THE ORDINARY. CALLER HAD NP ON THE LINE WITH THEM. NP STATED THAT TYPICALLY PATIENT'S GASTROPARESIS HAS BEEN WELL CONTROLLER AND INS WAS LAST INTERROGATED (B)(6) 2021 AND SHOWED THERAPY IMPEDANCE OF 608 OHMS WITH BATTERY READING OF LOW. HOWEVER, SINCE (B)(6), PATIENT HAS HAD A RETURN OF NAUSEA AND VOMITING SYMPTOMS AND PAIN AT INS SITE. NP STATED THAT, AT ONE POINT, PATIENT PRESENTED TO THE ER WITH A TEAR CAUSING THEM TO VOMIT BLOOD. NP STATED THAT PATIENT ALSO HAS CARDIAC COMPLICATIONS ALONG WITH UNCONTROLLED DIABETES SO IT WAS FIRST THOUGHT THAT PATIENT'S SYMPTOMS WERE POSSIBLY DUE TO OTHER MEDICAL EVENTS GOING ON. NP STATED THAT UPON INTERROGATION TODAY, INS WAS ON AND THERAPY IMPEDANCE WAS 608 OHM (WHICH WAS SIMILAR TO PREVIOUS INTERROGATIONS) AND AMPLITUDE WAS AT 7.2V DESPITE THAT, AT LAST VIS

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Internal Organ Perforation; Nausea; Pain; Vomiting

  MAUDE report 15786442 ↗
• InjurySep 16, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; 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 WITH THEIR FIRST ENTERRA DEVICE, THE LEAD WIRE BROKE INSIDE OF THEM 3 MONTHS AFTER IMPLANT. THEIR SYSTEM WAS REPLACED BECAUSE THE WIRES BROKE AND WAS LOOSE ON THE SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437435 ↗
• InjuryAug 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRO STIMULATION. IT WAS REPORTED THAT THE CALLER CALLED FOR INTERSTIM FECAL PHYSICIAN LISTINGS. CALLER MENTIONED DURING THE CALL THAT THEY NO LONGER USE THE GASTRIC STIMULATOR. CALLER REPORTED IT BROKE INSIDE OF THEM AND WAS EXPLANTED, 1 YEAR AFTER IMPLANT, BUT THEY DON'T REMEMBER THE DATE.

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

  MAUDE report 15315787 ↗
• InjuryAug 10, 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 GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT  TO ASK ABOUT CAUTERY COMPATIBILITY AND GI TUBE PLACEMENT. THE CALLER REPORTED THAT THEY PERFORMED A RESTING GASTRIC ULTRASOUND AND FOUND THE PATIENT TO HAVE EXCESSIVE GASTRIC VOLUME BY SEVERAL HUNDRED CC. THE CALLER ASKED ABOUT THE DEVICE OPERATION. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. TSS REVIEWED INFORMATION ABOUT THE IMPLANTED SYSTEM.

  Patient problems: Insufficient Information; Paresis

  MAUDE report 15200707 ↗
• InjuryJun 28, 2022Inappropriate/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 GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT IS GETTING A SHOCKING SENSATION AND WANTS IT REMOVED. EXPLANT IS PLANNED FOR (B)(6) 2022.

  Patient problems: Electric Shock

  MAUDE report 14841440 ↗
• InjuryJun 27, 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 GASTRIC STIMULATION AND GASTROPARESIS. IT WAS REPORTED THAT THE DEVICE WAS REMOVED BECAUSE IT WAS NON RESPONSIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14830255 ↗
• InjuryMay 19, 2022Break; Unintended Collision; Energy Output Problem; Electromagnetic Compatibility Problem; Positioning Problem; Break; Unintended Collision; Energy Output Problem; Electromagnetic Compatibility Problem; Positioning Problem

  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 (PT) EXPERIENCED A FALL LAST WEDNESDAY AND BROKE THEIR PELVIS AND KNEE. THE CALLER STATED THAT THE PT HAD SURGERY AND AS OF FRIDAY HAS BEEN EXPERIENCING NAUSEA AND STOMACH PROBLEMS. CALLER STATES THEY WOULD LIKE TO HAVE A REPRESENTATIVE COME TO THE MEDICAL CENTER WHERE THE PT IS STAYING TO CHECK THE PT'S DEVICE TO SEE IF IT'S STILL ON. THE CALLER WAS REDIRECTED TO PT SERVICES PROVIDED NAS NUMBER FOR HEALTHCARE PROVIDER TO REACH OUT TO THE REPRESENTATIVE.

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

  MAUDE report 14434276 ↗
• InjuryApr 15, 2022Break; Inappropriate/Inadequate Shock/Stimulation; Break; Inappropriate/Inadequate Shock/Stimulation

  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  DAY A COUPLE OF YEARS AGO AND FELT FUNNY THEN BY THE AFTERNOON AND EVENING COULD SEE THEIR STOMACH DOING JUMPS SO THEY CALLED THEIR DOCTOR, WENT IN AND THE DOCTOR COULD SEE THE STOMACH SPASMING AND ASKED THEM IF THEY HAD BEEN HIT IN THEIR STOMACH BUT THEY HAD NOT BEEN HIT IN THE STOMACH. PT SAID WHAT HAPPENED IS THE WIRES BROKE ON THEIR OWN ON THE INSIDE, IT ENDED UP CAUSING: SHOCK, SHOCK. PT SAID THEY HAD TO HAVE IT REPLACED. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED AT THIS TIME.

  Patient problems: Electric Shock; Insufficient Information

  MAUDE report 14117728 ↗
• MalfunctionMar 10, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT SAID THE DEVICE ALL OF A SUDDEN STARTED SHOCKING THEM. AGENT DID NOT ASK ABOUT THE CIRCUMSTANCES THAT LED TO THE REPORTED ISSUE. DOCUMENTED REPORTED EVENT. NO FURTHER ACTION WAS TAKEN BY PATIENT SERVICES.

  Patient problems: Electric Shock

  MAUDE report 13725349 ↗
• MalfunctionDec 7, 2021Battery Problem; Battery 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  THEY  INTERROGATED PATIENT'S IMPLANT TODAY AND DEVICE WAS IN "RESET MODE". CALLER SAID SHE CLEARED POR - POWER ON RESET THE FIRST TIME BUT THEN GOT THE MESSAGE AGAIN ON THE SECOND INTERROGATION. TECHNICAL SERVICES(TS) REVIEWED WITH CALLER THAT IF DEVICE KEEPS RESETTING AFTER THE POR IS CLEARED, THEN IT'S POSSIBLE THE IMPLANT HAS REACHED EOS, SINCE BATTERY CAN CONTINUE TO RESET ITSELF AT EOS. CALLER TO INTERROGATE AGAIN TO CONFIRM. CALLER HAS NO IDEA WHEN PATIENT STARTED HAVING ISSUE WITH THE IMPLANT. THE CALLER WAS NOT WITH THE PATIENT.  NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957307 ↗
• InjuryNov 12, 2021Battery Problem; Data Problem; Battery Problem; Data Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION. IT WAS REPORTED THAT FOR THE FIRST 4.5 YEARS, THE THERAPY WORKED WELL, HOWEVER IN THE PAST 2 OR MORE YEARS, THEY REPORTED HAVING EXPERIENCED MORE NAUSEA AND  HAD MORE FREQUENT DOCTOR'S APPOINTMENT TO ADJUST THE SETTINGS. THE PATIENT STATED THAT THE HEALTH CARE PROFESSIONAL (HCP) STAFF PERFORMING THE PROGRAMMING COMMENTED SEVERAL TIMES THAT THE SETTING WAS CHANGING BETWEEN APPOINTMENTS AND THAT THE NEUROSTIMULATOR BATTERY WAS DEPLETING. THE PATIENT SAID ON AN APPOINTMENT ON (B)(6) WITH THE NURSE PRACTITIONER, THE BATTERY WAS AT 7.6 AND ON (B)(6), THE BATTERY WAS AT 2.6. THE PATIENT SAID THAT DURING THIS TIME THEY WERE PRESCRIBED ZOFRAN. THE PATIENT SAID THAT THEY HAD THEIR FIRST CONSULT WITH A SURGEON YESTERDAY AND ASKED ABOUT IMPLANT PROCEDURE, WHETHER THE LEAD WOULD BE REPLACED AND SAID THAT THE SURGEON HAD FLATLY SAID ONLY THE NEUROSTIMULATOR AND WOULDN'T PROVIDE ANY FURTHER INFORMATION. THE PATIENT SAID THEY REVIEWED INFORMATION ON THE MANUFACTURER COMPANY'S WEBSITE ABOUT THE SURGERY AND WANTED TO REVIEW THE INFORMATION. THE PATIENT SERVICES AGENT CONSULTE

  Patient problems: Nausea

  MAUDE report 12808040 ↗
• InjuryOct 26, 2021Adverse 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 GASTRIC STIMULATION AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT REPORTED THEIR INS HAS DECREASED THEIR GASTROPARESIS SYMPTOMS. THE PATIENT REPORTED THEY WILL HAVE IT REMOVED IN AN UPCOMING BARIATRIC SURGERY ON NOVEMBER 10, THEY HOPE THE BARIATRIC SURGERY WILL HELP BOTH THE GASTROPARESIS SYMPTOMS AS WELL AS THE OTHER ISSUE. THE PATIENT DID NOT ELABORATE ABOUT THE "OTHER ISSUE". THE PATIENT WAS CALLING WAS TO ARRANGE FOR A CLINICIAN PROGRAMMER TO BE SENT TO THEIR DOCTOR TO TURN STIMULATIONS OFF PRIOR TO THE SURGERY. THE PATIENT ALSO REPORTED, LAST TIME THE PATIENT HAD SURGERY, THEY DID NOT EVEN HAVE THE STIMULATOR TURNED OFF BECAUSE THE CLINICIAN PROGRAMMER DID NOT ARRIVE ON TIME. THE PATIENT SAID THEY WANT TO AVOID DAMAGING THE STIMULATOR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12698592 ↗
• InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT  THE PATIENT DEVICE WAS EXPLANTED DUE TO INFECTION.  NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 12661568 ↗
• InjuryAug 25, 2021Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT (PT) STATED THE ENTIRE ENTERRA SYSTEM WAS REMOVED BECAUSE IT HAD MALFUNCTIONED AND WAS SHOCKING THEM PAINFULLY WHEN THEY LIFTED UP THEIR FOOT. PT ASKED THAT THE DEVICE BE SENT IN FOR ANALYSIS BUT THE DOCTOR NEVER DID. PT STATES THIS SHOCKING HAPPENED SO LONG AGO BUT THEY THINK IT WAS IN 2013. PT STATES THEY DIDN'T HAVE THE DEVICE IN MORE THAN A COUPLE OF MONTHS. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PATIENT WAS ALSO TRANSFERRED FROM DRS WHO IS UPDATING THE PATIENT'S INFORMATION. NO FURTHER COMPLICATIONS WERE REPORTED AT THIS TIME.

  Patient problems: Electric Shock

  MAUDE report 12363951 ↗
• MalfunctionAug 12, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ADDITIONAL INFORMATION INDICATED THAT IMPLANTED DEVICE WITH SERIAL (B)(6) WAS DISTRIBUTED ON (B)(6) 2013 NOT (B)(6) 2014, LEAD 435135 S/N: (B)(6) WAS (B)(6) 2012 NOT (B)(6) 2014 AND LEAD 435135 S/N: (B)(6) WAS (B)(6) 2013 NOT (B)(6) 2014.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315582 ↗
• InjuryAug 12, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT DURING KIDNEY/PANCREAS TRANSPLANT SURGERY THE LEADS WERE INADVERTENTLY CUT DUE TO ADHESIONS IN THE ABDOMEN. THE ENTIRE SYSTEM WAS REMOVED AT TIME HOPING THAT THE PATIENT WOULDN'T NEED ENTERRA AFTER HER SURGERY. THE PATIENT HOWEVER WAS RE-IMPLANTED ON (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 12315404 ↗
• InjuryMay 5, 2021Adverse 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 HCP REPORTED THAT THE INFECTION WAS NOT YET RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 11777553 ↗
• MalfunctionFeb 19, 2021Insufficient 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 GASTRIC STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR THERAPY. IT WAS REPORTED THAT THE PATIENT IS HAVING CONSTANT NAUSEA, VOMITING, ABDOMINAL PAIN AND NO MEDICATIONS ARE HELPING. CALLER REPORTS THIS HAS BEEN OCCURRING THE PAST 3 WEEKS. THE PATIENT CALLED TO REPORTED AGAIN THAT THEY ARE NOT SURE IF BATTERY IS STILL WORKING. THE PATIENT IS REQUESTING TO GET MANUFACTURER REPRESENTATIVE (REP) TO CHECK INS DUE TO THIS. THEY ARE NOT SURE IF HCP THAT CALLED YESTERDAY HAS HEARD BACK REGARDING REQUESTING REP AS HCP IS NOT IN OFFICE TODAY. REVIEWED PROCESS TO CONTACT REP AND REDIRECTED PATIENT TO HCP TO CONTACT/INQUIRE IF ABLE TO CONTACT REP. PROVIDED THE PATIENT WITH NAS PELVIC HEALTH NUMBER FOR HCP IF NEEDED.

  Patient problems: Abdominal Pain; Nausea

  MAUDE report 11350329 ↗
• MalfunctionFeb 16, 2021Insufficient Device Problem Information; 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 THE PATIENT IS TRYING TO LOCATE A PHYSICIAN FOR THEIR ENTERRA. PATIENT STATED THEY DO NOT THINK ITS WORKING PROPERLY BECAUSE PATIENT HAS BEEN SICK WITH NAUSEA THE PAST COUPLE OF WEEKS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Malaise; Nausea

  MAUDE report 11334771 ↗