BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3050122 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03544
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 21, 2013
    Report Date
    April 18, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 THAT THE ONLY A PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND SET SCREW MARKS WERE NOTED ON ALL TERMINAL CONNECTORS. IN ADDITION, THE RETURNED SEGMENT OF LEAD SHOWED THAT THE INSULATION WAS PARTIALLY ABRADED. IT APPEARED THAT THE ABRASION WAS CAUSED BY RUBBING AGAINST THE DISTAL TERMINAL LEG OF THE LEAD, HOWEVER NO CONDUCTORS WERE EXPOSING AT THIS LOCATION. THE RETURNED SEGMENT OF THE LEAD WAS ARCHIVED AT BOSTON SCIENTIFIC.

    Additional Manufacturer Narrative · 1

    TO DATE, THE EXPLANTED LEADS HAVE NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT THE LEADS WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD WERE REMOVED AND REPLACED DUE TO AN INSULATION ISSUED OBSERVED DURING A RECENT FOLLOW UP VISIT. IN ADDITION, THE LEADS EXHIBITED OVERSENSING WHICH RESULTED IN PACING INHIBITION FOR GREATER THAN TWO SECONDS OF ASYSTOLE. THE LEADS WERE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150244 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R