BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL DR

    MDR report key: 1896605 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05336
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 16, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BATTERY DEPLETION WAS OCCURRING FASTER THAN EXPECTED. BATTERY DATA WAS 2.71 V, 15 UA, 2.0 KOHMS, WITH A REMAINING LONGEVITY OF 1.3 TO 2.0 YEARS. HOWEVER, BASED ON THE GIVEN CURRENT DRAIN OF 15 UA, THE ESTIMATED REMAINING LONGEVITY FROM IMPLANT TO ELECTIVE REPLACEMENT INDICATOR (ERI) WAS CALCULATED TO BE 4.1 YEARS. A PATIENT FOLLOW-UP WAS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5820 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR