BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUNCTUA

    MDR report key: 3905279 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10637
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 23, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. INTERROGATION OF THE DEVICE CONFIRMED IT WAS IN SAFETY MODE AND IN A MONITOR + THERAPY STATUS. ATTEMPTS TO PROGRAM THE TACHY MODE OFF WERE UNSUCCESSFUL; THE DEVICE LATER REVERTED TO MONITOR + THERAPY AND ATTEMPTED TO DELIVER A SHOCK. THIS OCCURRED DURING DECONTAMINATION OF THE DEVICE, AS WELL AS DURING ANALYSIS. ATTEMPTS TO DOWNLOAD THE DEVICE MEMORY WERE UNSUCCESSFUL. THE DEVICE CASE WAS REMOVED AND THE BATTERY VOLTAGE MEASURED 2.234V, LOWER THAN THE REQUIRED VOLTAGE FOR DEVICE FUNCTION. SEVERE ELECTRICAL OVERSTRESS DAMAGE WAS OBSERVED ON THE INTEGRATED CIRCUIT. NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED. THE CIRCUIT WAS NO LONGER OPERATIONAL AND NO FURTHER TROUBLESHOOTING COULD BE PERFORMED DUE TO THE AMOUNT OF ARCING DAMAGE IN THE CIRCUIT, AND ROOT CAUSE COULD NOT BE DETERMINED DUE TO THE EXTENT OF THE DAMAGE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPORTED HEARING TONES. UPON INTERROGATION IT WAS OBSERVED THIS DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. A SHORT TIME LATER, THE DEVICE THEN CONVERTED TO SAFETY MODE WHICH PROVIDES BASIC LIFESAVING SHOCK THERAPY AND BASIC PACING. DUE TO THE STATUS OF THE DEVICE A SAVE-TO-DISK OF THE MEMORY WAS UNABLE TO BE PERFORMED FOR ANALYSIS. REPLACEMENT WAS RECOMMENDED AND THE DEVICE WAS SUCCESSFULLY EXPLANTED THE SAME DAY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382105 PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E053

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R 4470| T125| 0184| E143| E053