BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3961321 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13585
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) HAD NOT BEEN WORKING FOR THE LAST SIX MONTHS. IT WAS NOTED THE PATIENT WENT TO THEIR HEALTHCARE PROVIDER AND THEY WERE ABLE TO GET IT TO WORK AGAIN BUT IT DIED SHORTLY AFTER WITHIN TWO WEEKS. IT WAS STATED THE PATIENT FELT IT SHORTED OUT AND THEY COULD SEE THEIR STOMACH MOVE AND THAT NEVER HAPPENED BEFORE. THE PATIENT STATED IT WAS LOCATED ABOVE THEIR RIBS AND THEY THOUGHT THAT IS WHY IT WAS MESSING UP. THE PATIENT STATED ¿IT¿S OUT OF MY SKIN AND SITTING ABOVE MY RIB CAGE.¿ IT WAS NOTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THE PATIENT WAS SCHEDULED TO GET A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437637 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention