BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911733 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16780
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD AND DEVICE REMAIN IMPLANTED AND 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A DEVICE REPLACEMENT PROCEDURE WAS PERFORMED. AFTER THIS RIGHT VENTRICULAR LEAD WAS CONNECTED TO THE REPLACEMENT DEVICE, INITIAL MEASUREMENTS WERE WITHIN NORMAL RANGE. THE POCKET WAS CLOSED. MEASUREMENTS WERE AGAIN OBTAINED AND A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT WAS OBTAINED. IN "DISTAL COIL VERSUS CAN" CONFIGURATION, NORMAL SHOCK IMPEDANCE MEASUREMENT WAS OBTAINED. A DECISION WAS MADE TO LEAVE THIS DEVICE AND RIGHT VENTRICULAR LEAD IMPLANTED PROGRAMMED IN THAT SHOCK VECTOR CONFIGURATION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18465 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 0175| 4096| H195