BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3904351 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-08358
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 10, 2014
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RV LEAD WAS CAPPED AND SURGICALLY ABANDONED AND THEREFORE WILL NOT BE RETURNED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL REPLACEMENT PROCEDURE, IT WAS NOTED THAT THE PACING IMPEDANCE MEASUREMENTS WERE ABOVE 2,000 OHMS WHEN THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS CONNECTED TO THE CHRONIC RIGHT VENTRICULAR (RV) LEAD. THE PACING IMPEDANCE MEASUREMENTS TAKEN ON THE PACING SYSTEM ANALYZER (PSA) AND WITH THE PREVIOUS DEVICE WERE AT 1,400 OHMS. THE CONNECTION WAS CORRECT AND NO ANOMALIES WERE NOTED ON THE RV LEAD UNDER EXAMINATION. THE PHYSICIAN EXPLANTED THIS ICD AND CAPPED THE CHRONIC RV LEAD. A NEW ICD AND RV LEAD WERE THEN IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT WILL CONTINUE TO BE MONITORED CLOSELY. THE SERIAL NUMBER FOR THIS RV LEAD IS CURRENTLY UNKNOWN AND ATTEMPTS TO OBTAIN IT HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383771 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS GUIDANT PUERTO RICO BV 0148

    Patients

    Seq Age Sex Outcome Treatment
    1