BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 2973357 · Received February 21, 2013

    Report

    Report Number
    2938836-2013-00179
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 14, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    NO COMMUNICATION COULD BE ESTABLISHED BETWEEN THE DEVICE AND THE PROGRAMMER UPON RECEIPT. LOW BATTERY VOLTAGE WAS OBSERVED. WITH ANOTHER BATTERY ATTACHED, THE DEVICE FUNCTIONED NORMALLY. A LONGEVITY CALCULATION WAS PERFORMED WITH DEFAULT VALUES AS PROGRAMMED PARAMETER VALUES WERE NOT AVAILABLE AND WAS FOUND TO BE WITHIN THE EXPECTED LIMITS. THE ORIGINAL BATTERY WAS SENT TO THE VENDOR FOR FURTHER EVALUATION AND NO BATTERY ANOMALIES WERE DETECTED. THE CAUSE OF THE BATTERY DEPLETION REMAINS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING A PATIENT NOTIFIER. INTERROGATION REVEALED THE DEVICE WAS IN BACKUP MODE WITH HV THERAPY DISABLED. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76076 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 3207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR