BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY DR, DF4 CONNECTOR

    MDR report key: 2984320 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00539
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 8, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, NO COMMUNICATION COULD BE ESTABLISHED BETWEEN THE DEVICE AND THE PROGRAMMER. THE CAUSE OF THE LOSS OF COMMUNICATION WAS FOUND TO BE DUE TO A LOW BATTERY VOLTAGE. THE DEVICE WAS TESTED MANUALLY ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND NO HIGH CURRENT DRAIN SOURCES WERE OBSERVED. THE ORIGINAL BATTERY WAS SENT TO THE VENDOR FOR FURTHER EVALUATION AND NO BATTERY ANOMALIES WERE DETECTED. THE CAUSE OF THE LOW BATTERY VOLTAGE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW-UP, THE DEVICE COULD NOT BE INTERROGATED. DURING DEVICE REVISION, IT WAS NOTED THAT BLOOD WAS SEEN IN THE HEADER OF THE ICD IN BOTH PORTS AT THE CONNECTOR PIN. VISUAL INSPECTION SHOWED THE DEVICE WAS SWOLLEN. THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87631 FORTIFY DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2233-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR (B)(4)