BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1951414 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23009
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THIS PATIENT HAD A RIGHT BUNDLE BRANCH BLOCK AND ANOTHER MANUFACTURER'S THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). IT WAS REPORTED THAT THIS IMPLANTABLE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS OVERSENSING THE P-WAVE AND LED TO PACING INHIBITION. THERE WAS NO SPECIFIC TIME PERIOD PROVIDED REGARDING THE LENGTH OF THE PACING INHIBITION OR IF THIS PATIENT WAS PACEMAKER DEPENDENT. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR 0185