BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 4855655 · Received June 17, 2015

    Report

    Report Number
    3009448963-2015-00363
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 8, 2015
    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

    THE FIELD REP WAS CONTACTED FOR ADD'L INFO. IF ADD'L INFO BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THE PT IMPLANTED WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) RECENTLY HAD A NON-DEVICE RELATED PROCEDURE AND NO TONES COULD BE HEARD FROM THE DEVICE WHEN PLACING A MAGNET. THE PT WAS CONCERNED THAT THE BATTERY WAS DEPLETED AS THEY RECEIVED A SHOCK THE WEEK BEFORE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND DISCUSSED MAGNET/TONE FUNCTION, STATING TONES ARE ONLY EMITTED FOR THE FIRST 60 SECONDS, THEN STOPS. THE PHYSICIAN EXPLAINED THAT HE DIDN'T HEAR TONES WHEN THE MAGNET WAS FIRST PLACED OVER THE DEVICE. TS DISCUSSED IT IS POSSIBLE THAT THERAPIES WERE DEACTIVATED PREVIOUSLY. THE PHYSICIAN STATED THE DEVICE SHOCKED THE PT ABOUT A WEEK AGO. TS MENTIONED AGAIN THAT THERAPIES MAY HAVE BEEN DEACTIVATED AT THAT TIME AND RECOMMENDED A DEVICE CHECK. THE PHYSICIAN PLANNED TO CONTACT HIS EP DEPT AND SAID HE WOULD CALL BACK IF HE NEEDED TO HAVE A LOCAL BOSTON SCIENTIFIC FIELD REP CONTACTED. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395579 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH INC. 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR 3010