BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT DR RF

    MDR report key: 1896355 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05375
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 19, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. FINAL ANALYSIS FOUND AN INTERNAL SHORT IN THE BATTERY. THIS WAS THE CAUSE OF THE REPORTED EXCESSIVE BATTERY DISCHARGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED EXCESSIVE BATTERY DISCHARGE. THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR ON (B)(6) 2010, WITH BATTERY VALUES OF 2.59 V AND 8 UA. ON (B)(6) 2009, THE BATTERY VOLTAGE WAS 2.85 V WITH AN ESTIMATED 3.2 TO 4.4 YEARS REMAINING LONGEVITY. THE PULSE GENERATOR WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION PM2210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention