BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3052685 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04008
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    December 26, 2012
    Report Date
    March 6, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND TRILUMEN INSULATION DAMAGE AND THE CONDUCTOR WAS EXPOSES APPROXIMATELY 37-38 CM FROM IS-1 TERMINAL PIN. DUE TO LOCATION AND TYPE OF DAMAGE IT IS MOST LIKELY CAUSED BY ENTRAPMENT IN THE CLAVICLE/ FIRST-RIB REGION. THE LEAD WAS ARCHIVED AT BOSTON SCIENTIFIC.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS REMOVED AND REPLACED DURING A RECENT DEVICE CHANGE OUT. NOISE AND OVERSENSING OCCURED ON THE RV CHANNEL DUE TO AN RIGHT ATRIAL (RA) COMPETITOR LEAD DISLOGMENT.THE NOISE AND OVERSENSING DID NOT LEAD TO PACING INHIBITTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154682 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR MISMATCH| 1688T| 1871| 0158