BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1860227 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-14872
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 22, 2010
    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

    THE ASSOCIATED DEVICE WAS REPROGRAMMED TO INCREASE THE PACING OUTPUTS. AT THIS TIME, THIS DEFIBRILLATION LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD PRESENTED WITH HIGH PACING IMPEDANCE MEASUREMENTS OVER THE LAST TWELVE MONTHS. THE MEASUREMENTS HAVE VARIED BETWEEN 1900 AND 2276 OHMS. IN ADDITION, THE THRESHOLDS WERE ALSO VARIABLE BETWEEN 2.2 AND 4 VOLTS. ALL OTHER LEAD MEASUREMENTS WERE WITHIN NORMAL PARAMETERS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 4512| H195| H155| 0148