BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2172871 · Received July 22, 2011

    Report

    Report Number
    2124215-2011-10070
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 9, 2011
    Report Date
    September 20, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION REVEALED THREE TERMINAL LEGS WERE RETURNED AND THE LEAD WAS SEVERED. ANALYSIS DETERMINED THE LEAD WAS ELECTRICALLY CONTINUOUS. DUE THE DAMAGED CONDITION OF THE LEAD, NO FURTHER TESTING WAS PERFORMED. ANALYSIS COULD NOT CONFIRM THE REPORTED CLINICAL OBSERVATION.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD AND DEVICE REMAIN IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT POST LEFT VENTRICULAR ASSIST DEVICE PROCEDURE, NO OVERSENSING WAS REVEALED. THE PATIENT WITH THIS DEVICE AND RIGHT VENTRICULAR LEAD HAS AN INTRINSIC ATRIAL ARRHYTHMIA WITH FAST VENTRICULAR CONDUCTION. THE DEVICE HAD BEEN REPROGRAMMED TO AVOID INAPPROPRIATE THERAPY. DURING A FOLLOW UP VISIT, NOISE CAUSING OVERSENSING AND PACING INHIBITION GREATER THAN TWO SECONDS ASYSTOLE WAS NOTED ON THE RIGHT VENTRICULAR ELECTROGRAM. IN ADDITION, NOISE WAS NOTED ON THE SHOCK ELECTROGRAM. THE PATIENT HAD EXPERIENCED AN INAPPROPRIATE SHOCK. THE DEVICE WAS REPROGRAMMED TO MONITOR ONLY. AS THE DEVICE HAS REACHED END OF LIFE AND IS FOR MONITORING PURPOSES ONLY, NO INTERVENTION DECISION HAS BEEN MADE AS OF THIS DATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other H199