BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM DR

    MDR report key: 2810853 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03752
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z261/Z-262-0
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE SYSTEM REMOVED DUE TO INFECTION AND MYOCARDITIS. A NEW LEAD WAS IMPLANTED AND WAS CONNECTED TO AN EXTERNAL PACEMAKER UNTIL THE INFECTION RESOLVES. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC, INC. 7271

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R