BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM

    MDR report key: 250329 · Received April 8, 1999

    Report

    Report Number
    2647346-1999-00057
    Event Type
    Injury
    Date Received
    April 8, 1999
    Date of Event
    February 9, 1999
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LOW BATTERY VOLTAGE 1 MO POST IMPLANT. 3/29/99 - LOW BATTERY VOLTAGE 2 MO POST IMPLANT, DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM Implant IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7227CX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other 6943 IMPLANTABLE TACHY LEAD