BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 1170711 · Received September 16, 2008

    Report

    Report Number
    3004209178-2008-05772
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 17, 2008
    Report Date
    August 17, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT HAS HAD THE STIMULATOR FOR ONE YEAR AND UNTIL RECENTLY IT APPEARED SHE NO LONGER EVENT HAD GASTROPARESIS. SHE RECENTLY HAD A BRAVO PH TEST IMPLANT FOR 48 HOURS AND ?IT IS BACK TO LIKE I NEVER HAD THE IMPLANT PUT IN?. SYMPTOMS WERE VOMITING, NAUSEA AND ALL OVER UN-WELL FEELING. REPORTEDLY,?THE PACER MALFUNCTIONED THE BRAVO CAPSULE AND THE BRAVO CAPSULE SEEMED TO BECOME MAGNETIZED OR SOMETHING? KNOCKING BUT THE STOMACH ENTERRA STIMULATOR IMPLANT AND CAUSING EXTREME PROBLEM. THE PACER TURNED OFF AND THE BRAVO CAPSULE REFUSED TO DISCARD ITSELF AS IF IT WERE BEING HELD THERE BY MAGNETS. FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA LNQ MEDTRONIC PUERTO RICO OPERATIONS CO 3116 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 LEAD: MODEL 4351| EXPLANTED:| EXPLANTED:| LEAD: MODEL 4351