BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 3891417 · Received November 26, 2013

    Report

    Report Number
    3009448963-2013-00132
    Event Type
    Malfunction
    Date Received
    November 26, 2013
    Date of Event
    November 20, 2013
    Report Date
    November 20, 2013
    Manufacturer
    CAMERON HEALTH INC
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE DEVICE IS EXPLANTED, IT WIL 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 WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) DIED FORM AN INFECTION NOT RELATED TO THE DEVICE. THREE DAYS LATER, THE FIELD REPRESENTATIVE WENT TO THE HOSPITAL TO DEACTIVATE THE DEVICE; HOWEVER, HE WAS UNABLE TO ESTABLISH TELEMETRY. THERE WERE NO ALLEGATIONS AGAINST THE FUNCTIONALITY OF THE DEVICE OR THAT IT CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE FIELD REPRESENTATIVE NOTIFIED THE PHYSICIAN TO USE A MAGNET WHEN EXPLANTING THE DEVICE. THE DEVICE WILL BE EXPLANTED WHEN THE AUTOPSY IS PERFORMED LATER IN THE WEEK. THE PHYSICIAN HAD ALSO NOTED THAT THERE HAD NOT BEEN ANY ISSUES IN THE PAST WITH INTERROGATING THIS DEVICE. THE FIELD REPRESENTATIVE CONFIRMED THAT HE PATIENT WAS IN COLD STORAGE FOR MORE THAN 72 HOURS BEFORE THE TELEMETRY WAS ATTEMPTED. IT WAS ALSO REPORTED THAT THE PATIENT HAD NOT BEEN EXPOSED TO AN MRI PRIOR OR EXTERNAL DEFIBRILLATION PRIOR TO THEIR DEATH. THE PROGRAMMER USED TO INTERROGATE THE DEVICE IS FUNCTIONAL AND WAS ABLE TO INTERROGATE OTHER DEVICES SUCCESSFULLY. A MAGNET WAS NOT APPLIED AT THE TIME OF THE INTERROGATION SO IT IS UNKNOWN IF THE DEVICE CAN RESPOND TO A MAGNET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617340 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH INC 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 3010