BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3212597 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09219
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 30, 2013
    Report Date
    July 30, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT REMOTE MONITORING OF THIS RIGHT VENTRICULAR LEAD DISPLAYED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. THIS INFORMATION WAS PROVIDED TO THE PHYSICIAN FOR THEIR REVIEW AND IS BEING MONITORED. A LEAD REVISION IS INTENDED AND UPON REMOVAL, THE LEAD WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED FOR ANALYSIS APPROXIMATELY 2 YEARS AFTER THE ORIGINAL REPORT OF THE HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS. ANALYSIS OF THE ICD WAS UNABLE TO CONFIRM THE OBSERVED IMPEDANCE MEASUREMENTS AS THE DEVICE OPERATED ACCORDING TO SPECIFICATION. PER LABORATORY FINDINGS, EXPLANT OF THE DEVICE OCCURRED WITHIN APPROXIMATELY ONE MONTH OF THE INITIAL REPORT OF OUT-OF-RANGE IMPEDANCES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO FURTHER DETAILS REGARDING THE REVISION PROCEDURE COULD BE OBTAINED. AVAILABLE INFORMATION INDICATES THIS LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312050 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1