BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2053246 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03949
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 2, 2011
    Report Date
    January 21, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN WILL CONTINUE TO MONITOR THE ISSUE. ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LEAD WAS SUBSEQUENTLY RETURNED FOR TESTING. UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE RETURNED THREE SEGMENTS WAS PERFORMED. VISUAL INSPECTION NOTED THE LEAD HAD BEEN SEVERED. RESISTANCE TESTING CONFIRMED THE ELECTRICAL CONTINUITY OF EACH OF THE THREE LEAD SEGMENTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AT A FOLLOW UP APPOINTMENT THERE WAS NOTE UPON INTERROGATION TO CHECK THE RIGHT VENTRICULAR LEAD. THERE WERE NO OUT-OF-RANGE MEASUREMENTS AND NO NOISE PRESENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 4136| 0185| 4543| N119