BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM III AT

    MDR report key: 1854898 · Received October 5, 2010

    Report

    Report Number
    6000144-2010-04311
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 27, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980050/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION: CHANGED ADVERSE EVENT TO 'YES' AND DATE OF DEATH FIELD TO 'NOT APPLICABLE'. EVALUATION SUMMARY: (B)(4) BATTERY DEPLETION-NORMAL.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BATTERY PREMATURELY DEPLETED AND WAS REPLACED BEFORE FIVE YEARS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM III AT ASKU LWS MEDTRONIC MED REL, INC. 7276 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD