BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 8754660 · Received July 2, 2019

    Report

    Report Number
    3004209178-2019-12817
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    May 9, 2019
    Report Date
    July 2, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LNQ
    UDI-DI
    00643169360686
    PMA / PMN Number
    H990014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION. IT WAS REPORTED THAT THE PATIENT¿S IMPLANT WAS TOTALLY DEAD; IT WAS CLARIFIED THAT THE INS WAS VERY LOW AND MAY NEED TO BE REPLACED. IT WAS NOTED THAT THE PATIENT SAW A HEALTHCARE PROVIDER (HCP) AND AFTER HAVING A SMART PILL TEST, IT WAS DETERMINED THAT THE PATIENT DID NOT HAVE GASTROPARESIS BASED ON THE PILL AND THE PATIENT WAS NOT SURE WHAT TO DO. ADDITIONAL INFORMATION RECEIVED FROM A CONSUMER (CON). IT WAS REPORTED THAT, A COUPLE MONTHS PRIOR, THE BATTERY WAS NOT LOW. THEY WERE NOT ALLEGING DISSATISFACTION WITH LONGEVITY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY STATED THE DOCTOR DID NOT WANT TO CHANGE THE BATTERY UNTIL THEY DID A CAT SCAN, GASTRIC EMPTYING STUDY, AND EGD. THEY STATED THEY WERE GIVEN A SMART PILL AND THE BATTERY DEPLETED WITHIN DAYS OF SWALLOWING IT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT¿S LEGAL REPRESENTATION. THEY STATED ON (B)(6) 2018 THEY SAW THEIR GASTROENTEROLOGIST WHO OPINED THAT THERE WAS APPROXIMATELY 1-2 YEARS OF BATTERY LIFE REMAINING. ON (B)(6) 2019 THEY SAW THEIR LOCAL SURGEON WHO LOWERED THE SETTINGS AND ALSO CONFIRMED THE SAME BATTERY LIFE INFORMATION. ON (B)(6) 2019 THE PATIENT WAS ADMINISTERED A SMART PILL CAPSULE ENDOSCOPY WITH THE INS STILL ACTIVE. THE PATIENT THEN MET WITH THEIR GASTROENTEROLOGIST WHO STATED THE BATTERY WAS EXTREMELY LOW. THEY STATED THE PATIENT IS NOW FACING A POTENTIAL BATTERY REPLACEMENT SOONER THAN ANTICIPATED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549520 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC PUERTO RICO OPERATIONS CO. 37800 00643169360686

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR