BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3955853 · Received July 24, 2014

    Report

    Report Number
    2124215-2014-14466
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 14, 2014
    Report Date
    August 12, 2014
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. VISUAL INSPECTION NOTED A BURN MARK ON THE FRONT OF THE DEVICE CASE. REVIEW OF DEVICE MEMORY FOUND A SHORTED LEAD FAULT WAS RECORDED ON (B)(6) 2014. AN X-RAY OF THE DEVICE REVEALED THAT THE INTERNAL HIGH VOLTAGE FUSE WAS DAMAGED (I.E., NO LONGER INTACT). THE DAMAGE TO THE FUSE MOST LIKELY OCCURRED DURING DELIVERY OF THE SHOCK THAT RESULTED IN THE SHORTED SHOCK LEAD FAULT. THE DAMAGE TO THE HIGH VOLTAGE FUSE PREVENTED ANY SUBSEQUENT CHARGING OF THE HIGH VOLTAGE CAPACITORS AND DELIVERY OF SHOCK THERAPY. AS A RESULT, A HIGH VOLTAGE CHARGE ATTEMPT CAUSED THE DEVICE TO DECLARE EOL BECAUSE IT COULD NOT SUCCESSFULLY COMPLETE CHARGING WITHIN 30 SECONDS, DESPITE THE FACT THAT SIGNIFICANT BATTERY VOLTAGE (THE DEVICE WAS AT 3.094 VOLTS AT THE TIME OF LABORATORY ANALYSIS) AND CAPACITY REMAINED. LABORATORY ANALYSIS CONCLUDED THAT THIS DEVICE WAS DAMAGED AFTER DELIVERING A SHOCK AFTER BEING EXPLANTED, POST-MORTEM.

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND ASSOCIATED RIGHT VENTRICULAR (RV) LEAD DIED AFTER CHOKING AT DINNER. THE DEVICE AND RV LEAD WERE EXPLANTED AT THE PATIENT'S HOME SHORTLY AFTER THE PATIENT PASSED AWAY. HOWEVER, TACHYCARDIA THERAPY WAS NOT PROGRAMMED OFF, AND WHEN THE DEVICE WAS INTERROGATED, FAULT CODES FOR A SHORTED LEAD CONDITION AND A CHARGE TIME OUT WERE OBSERVED. THE DEVICE WAS AT END OF LIFE (EOL) BATTERY STATUS DUE TO THE CHARGE TIME OUT. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT REVIEWED THE DEVICE DATA AND CONFIRMED THAT THE FAULT CODES OCCURRED POST-MORTEM, DUE TO THE DEVICE NOT BEING PROGRAMMED OFF. HOWEVER, THE PHYSICIAN WAS ALSO CONCERNED THAT THE DEVICE DEPLETED PREMATURELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433516 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK GUIDANT PUERTO RICO BV F163

    Patients

    Seq Age Sex Outcome Treatment
    1 F163