BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 5252997 · Received November 27, 2015

    Report

    Report Number
    3009448963-2015-00691
    Event Type
    Malfunction
    Date Received
    November 27, 2015
    Date of Event
    November 11, 2013
    Report Date
    November 2, 2015
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    UDI-DI
    00802526521362
    PMA / PMN Number
    P11042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE S-ICD REMAINS IMPLANTED AND IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN INTERNAL LOG FILE REVIEW, IT WAS DISCOVERED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) HAD DISPLAYED A DA ERROR MESSAGE. IT WAS DETERMINED THAT A MEMORY INCONSISTENCY OCCURRED THAT WAS SELF-CORRECTED BY THE DEVICE. THE S-ICD WAS FUNCTIONING NORMALLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783036 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010 00802526521362

    Patients

    Seq Age Sex Outcome Treatment
    1 3400