BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210377 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06625
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 16, 2013
    Report Date
    May 30, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS CONFIRMED THE INNER CONDUCTOR COIL WAS FRACTURED AT APPROXIMATELY 34 CM FROM THE TERMINAL PIN. DETAILED ANALYSIS OF THE FRACTURE SITE DETERMINED THE CONDUCTOR COIL WAS FRACTURED DUE TO CYCLIC FATIGUE.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD DISPLAYED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. IN ADDITION, LOSS OF CAPTURE WAS OBSERVED. A REVISION PROCEDURE IS PERFORMED. THIS LEAD WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310560 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R 4554| P107| 4542| 4096| 0185| 0181