BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4252958 · Received November 12, 2014

    Report

    Report Number
    3009448963-2014-00314
    Event Type
    Injury
    Date Received
    November 12, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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 INFO FROM A PRODUCT EXPERIENCE REPORT (PER) FORM THAT THIS PT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LAB. THE DEVICE AND ELECTRODE WERE EXPLANTED DUE TO INFECTION. THERE WERE NO FURTHER ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729513 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R 3010