BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 3030980 · Received March 28, 2013

    Report

    Report Number
    3009448963-2013-00030
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 15, 2013
    Manufacturer
    CAMERON HEALTH INC
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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 THIS PATIENT FROM (B)(6)TRAVELED TO (B)(6) WHERE THEY HAD A THERAPY EVENT AND REVIEW OF THE DEVICE WAS REQUESTED. UPON REVIEW OF THE DEVICE STORED MEMORY, IT APPEARED A DELAY IN THERAPY OF APPROXIMATELY 58 SECONDS OCCURRED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND REVIEWED THE STORED EPISODES. THE REASON THAT TIME TO THERAPY WAS LONGER THAN EXPECTED APPEARS TO BE DUE TO A SERIES OF PREMATURE VENTRICULAR CONTRACTIONS WHICH CAUSED THE AVERAGE OF THE LAST TWO PEAKS AMPLITUDE TO BE MUCH HIGHER THAN THE OVERALL RHYTHM. THERE WERE ALSO NOISE MARKERS PRESENT AFTER WHICH WAS AFFECTING THE PROFILE FROM CHANGING BACK TO TACHY SENSING. THE DEVICE DID DELIVER APPROPRIATE THERAPY AND CONVERTED THE RHYTHM BACK TO SINUS RHYTHM. OF NOTE, THE PATIENT HAD BEEN PARACHUTING AT THE TIME OF THE EVENT AND THE PHYSICIAN WAS SATISFIED WITH THE DEVICE PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128404 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR - PROD CODE LWS LWS CAMERON HEALTH INC 1010

    Patients

    Seq Age Sex Outcome Treatment
    1