BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2170329 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10382
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    May 31, 2011
    Report Date
    July 14, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS LATER RETURNED FOR ANALYSIS. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED A PUNCTURE HOLE IN THE LEAD INSULATION THROUGH THE RATE/SENSE (RS-) AND DISTAL HIGH VOLTAGE LUMENS 355 MILLIMETERS FROM THE TERMINAL PIN. BODY FLUID WAS NOTED IN THE RS- AND DISTAL HIGH VOLTAGE LUMENS. THE RS- GORE WAS BUNCHED IN SEVERAL PLACES. SOME OF THE COILS WERE OUT OF ALIGNMENT DUE TO THE BUNCHED GORE. A CUT WAS ALSO NOTED IN THE DISTAL SPRING ELECTRODE GORE. THE PROXIMAL END OF THE DISTAL SPRING ELECTRODE WAS SEPARATED FROM THE LEAD BODY INSULATION. ADDITIONAL VISUAL INSPECTION NOTED THE HELIX WAS RETRACTED AND BODY FLUID WAS NOTED IN THE HELIX HOUSING. RESISTANCE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. A LABORATORY TECHNICIAN TESTED THE HELIX MECHANISM AND FOUND IT WAS NONFUNCTIONAL, CONFIRMING THE CLINICAL OBSERVATION. THE IRREGULARITY IN HELIX FUNCTION WAS LIKELY DUE TO THE BODY FLUID IN THE HELIX HOUSING, HOWEVER THE LEAD BODY DAMAGE MAY HAVE CONTRIBUTED. LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED LEAD DISLODGEMENT.

    Additional Manufacturer Narrative · 1

    THIS LEAD HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED LOSS OF CAPTURE AND OUT OF RANGE IMPEDANCE MEASUREMENTS. IT WAS FOUND THAT THE LEAD HAD DISLODGED. A REVISION PROCEDURE WAS PERFORMED AND AN ATTEMPTED TO REPOSITION THE LEAD WAS MADE. HOWEVER, DIFFICULTY EXTENDING THE HELIX MECHANISM WAS EXPERIENCED. THE INSULATION OF THE LEAD WAS ALSO PUNCTURED DURING THE PROCEDURE. THIS LEAD WAS EXPLANTED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. 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 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention 0181| 7122| E102