BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173838 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-10950
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 20, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATION INDICATED THIS LEAD WAS RETURNED SEVERED 450 MM FROM THE TERMINAL PIN. THERE WERE SETSCREW MARKS NOTED ON THE IS-1 TERMINAL PIN, AND ON THE PROXIMAL AND DISTAL HIGH VOLTAGE (HV) TERMINAL PINS. THERE WERE CUTS NOTED IN THE INSULATION. ANALYSIS CONFIRMED THE FILARS AT THE DISTAL END OF THE PIGTAIL, BETWEEN THE PIGTAIL AND THE PROXIMAL SPRING ELECTRODE, WERE FRACTURED. THIS APPEARED TO BE RELATED TO THE EXPLANT PROCEDURE. ANALYSIS ALSO CONFIRMED INSULATION DAMAGE, WHICH COULD HAVE CONTRIBUTED TO THE INITIAL ALLEGATION OF NOISE AND OVERSENSING. DUE TO THE LOCATION AND TYPE OF DAMAGE IT WAS SUSPECTED THIS WAS CAUSED BY ENTRAPMENT IN THE CLAVICLE/FIRST RIB REGION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS REPLACED DUE TO NOISE, AND OVERSENSING. DURING THE REPOSITIONING OF THIS RV LEAD, THE PROXIMAL COIL GOT STUCK IN THE SVC. THE DECISION WAS MADE TO SURGICALLY ABANDON THIS RV LEAD. A NEW RV LEAD WAS SUCCESEFULLY CONNECTED TO ASSOCIATED DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR F102| 0158