BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC

    MDR report key: 595310 · Received April 18, 2005

    Report

    Report Number
    595310
    Event Type
    Other
    Date Received
    April 18, 2005
    Date of Event
    September 16, 2002
    Report Date
    April 18, 2005
    Manufacturer
    MEDTRONIC INC.
    Product Code
    LWS
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC RECALL OF ICD GENERATOR DEVICE SECONDARY TO POSSIBLE BATTERY MALFUNCTION. 70 YEAR OLD MALE W/ HISTORY OF CORONARY ARTERY DISEASE STATUS POST CORNARY ARTERY BYPASS GRAFT, ISCHEMIC CARDIOMYOPATHY AND SUDDEN CARDIAC ARREST IN 2002. DUAL CHAMBER ICD IMPLANT FOR VENTRICULAR TACHYCARDIA. PATIENT WAS NOTIFIED BY THE PHYSICIAN OF A MEDTRONIC RECALL ALERT. RECALL INFORMATION CAUSED GREAT DEAL OF ANXIETY FOR PATIENT AND WAS CONSTANTLY WORRYING ABOUT DEVICE AND IF IT IS FUNCTIONING APPROPRIATELY. SCHEDULED FOR ICD GENERATOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ICD LWS MEDTRONIC INC. 7274 *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR