BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 3841093 · Received May 16, 2014

    Report

    Report Number
    3009448963-2014-00082
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    April 23, 2014
    Report Date
    November 8, 2016
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    UDI-DI
    00802526521362
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFO CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFO BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS S-ICD DEVICE RECEIVED MULTIPLE INAPPROPRIATE SHOCKS DUE TO OVERSENSING HOWEVER REPORTEDLY, ONLY DURING PERIODS OF PHYSICAL ACTIVITY. THE CONDITION RESULTED IN RHYTHM ACCELERATION AND SYNCOPE, AT WHICH TIME THE PT SOUGHT MEDICAL CARE. AN ELECTROGRAM ANALYSIS, CONFORMED THAT DURING PERIODS OF INCREASED HEART RATE (EXERCISE), THE PT EXHIBITED A BROAD COMPLEX BUNDLE BRANCH BLOCK. THE FIELD REPRESENTATIVE CONFIRMED THE PATTERN WAS NOT EVIDENT DURING PERIODS OF REST. IT WAS ADDITIONALLY REPORTED THAT NO EXERCISE TESTING HAD BEEN PERFORMED PRIOR TO IMPLANT TO ILLUSTRATE THIS BEHAVIOR. DURING FOLLOW-UP EXERCISE TESTING, THE SECONDARY VECTOR SHOWED THE MOST OPTIMAL/ROBUST PROGRAMMING FOR THE PT: THE DEVICE WAS STATED THAT SHOULD THE BEHAVIOR CONTINUE THE SYSTEM WOULD BE EXPLANTED AND REPLACED WITH A CONVENTIONAL ICD SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293335 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010 00802526521362

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R 3010| 3010| 3010