BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 3130283 · Received May 22, 2013

    Report

    Report Number
    3009448963-2013-00063
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 15, 2013
    Manufacturer
    CAMERON HEALTH INC
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 A NORMAL PATIENT FOLLOW UP, A RED SCREEN APPEARED WHEN THIS DEVICE WAS INTERROGATED THAT STATED TO CALL TECHNICAL SERVICE. NO ISSUES WERE NOTED. THE DEVICE WAS INTERROGATED A SECOND TIME AND MEMORY DOWNLOAD WAS PERFORMED. THE DATA WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR EVALUATION. A TS CONSULTANT REVIEWED THE DATA AND DISCUSSED THAT THE DEVICE ALERTED FOR A DA ERROR, OR A TEMPORARY MEMORY CORRUPTION IN THE DEVICE FIRMWARE. IT WAS DISCUSSED THAT IT IS A BENIGN ERROR AND THAT THERAPY IS STILL AVAILABLE TO THE PATIENT. THE TS CONSULTANT PROVIDED RECOMMENDATIONS FOR THE FIELD REPRESENTATIVE. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227253 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR - PROD CODE LWS LWS CAMERON HEALTH INC 1010

    Patients

    Seq Age Sex Outcome Treatment
    1