BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK DSP

    MDR report key: 2052622 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04185
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    November 18, 2010
    Report Date
    February 24, 2011
    Manufacturer
    CPI PLANT - LEWICKI
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION WAS PERFORMED AND THIS RV LEAD WAS SUCCESSFULLY REPLACED. IT IS UNKNOWN IF THE LEAD WILL BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE. 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 RED ALERT WAS ISSUED THROUGH THE LATITUDE SYSTEM THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED A HIGH SHOCK IMPEDANCE MEASUREMENT. AT THE TIME, THE MANUFACTURER, MODEL, AND SERIAL NUMBER FOR THE ASSOCIATED RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS UNKNOWN. ADDITIONAL INFORMATION WAS LATER REPORTED THAT AT THE LAST PATIENT FOLLOW UP INDUCTION TESTING WAS PERFORMED AND RESULTED IN A SHOCK IMPEDANCE MEASUREMENT OF 60 OHMS. ADDITIONAL INFORMATION WAS REPORTED THAT ANOTHER INDUCTION TEST WAS PERFORMED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DUE TO OUT OF RANGE SHOCK IMPEDANCES. DURING TESTING, AN ERROR WAS DISPLAYED STATING THAT AN OPEN CIRCUIT CONDITION WAS DETECTED. MEASUREMENTS WERE TAKEN ON THE RIGHT VENTRICULAR (RV) LEAD AND SENSING AND PACING MEASUREMENTS WERE NORMAL. IT IS SUSPECTED THAT ONE OF THE RV LEAD'S HIGH VOLTAGE CONDUCTORS IS FRACTURED. DETAILED INFORMATION ON THE LEAD WAS OBTAINED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK DSP IMPLANTABLE LEAD NVY CPI PLANT - LEWICKI 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other 0125| 1720