BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 5998124 · Received October 4, 2016

    Report

    Report Number
    3004209178-2016-20392
    Event Type
    Injury
    Date Received
    October 4, 2016
    Date of Event
    September 6, 2016
    Report Date
    December 13, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS INTERROGATED BY THEIR HEALTH CARE PROVIDER (HCP) ON (B)(6) 2016 AND IT WAS FOUND TO BE SO LOW THAT THE HCP DIDN'T WANT TO INCREASE STIMULATION. THE HCP TOLD THE PATIENT THE INS WOULD HAVE TO BE REPLACED IN ABOUT A WEEK. THE PATIENT WAS VERY DISAPPOINTED THAT THE THERAPY ONLY LASTED FOR 1 YEAR. THE PATIENT HAD EXTREMELY HIGH SETTINGS SINCE THEY HAD ALMOST NO NERVE ENDINGS GOING TO THEIR STOMACH, BUT THOUGHT THE MANUFACTURER SHOULD STILL BE ABLE TO MANUFACTURE A DEVICE THAT COULD LAST SEVERAL YEARS EVEN IF IT WAS RAN ON HIGH SETTINGS. THE BATTERY LIFE ON THE PATIENT'S NEWER MODEL INS WAS NOT LASTING ACCORDING TO THEIR HCP. THERAPY WAS HELPING AND AT THE PATIENT'S LAST GASTRO-TEST THEY WENT FROM 30 PERCENT FOOD LEFT IN THE STOMACH TO ONLY 15 PERCENT FOOD LEFT IN THE STOMACH AFTER 4 HOURS. THE INDICATIONS FOR USE FOR THIS PATIENT WERE GASTRIC STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THE PATIENT REPORTED THAT THE CAUSE OF THE INS NOT LASTING WAS DUE TO HIGH SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648902 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC PUERTO RICO OPERATIONS CO. 37800

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention