BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK SQ ARRAY

    MDR report key: 659648 · Received November 14, 2005

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    Report

    Report Number
    2124215-2005-11173
    Event Type
    Malfunction
    Date Received
    November 14, 2005
    Date of Event
    August 30, 2005
    Report Date
    August 30, 2005
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THE PATIENT RECEIVED TWO SHOCKS FROM THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND ASSOCIATED SUBCUTANEOUS ARRAY DEFIBRILLATION LEADS WITHIN A FEW DAYS AND FOLLOWING THE DELIVERY OF THE SHOCKS, THE DEVICE BEGAN TO EMIT TONES. UPON INTERROGATION, THERE WAS AN ERROR CODE INDICATING THAT A SHORTED LEAD CONDITION HAD OCCURRED. THE PATIENT STATED THAT HE HAS RECEIVED SHOCKS FROM THE DEVICE IN THE PAST AND THAT THE RECENT SHOCKS DID NOT FEEL AS STRONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK SQ ARRAY IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0048 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other