BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4152484 · Received July 14, 2014

    Report

    Report Number
    3009448963-2014-00147
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 24, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 THAT ONE MONTH AFTER THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AND ELECTRODE WERE IMPLANTED, THE PT PRESENTED WITH REDNESS AT THE POCKET SITE AND THERE WAS PUS PRESENT ON THE WOUND. THE PT WAS HOSPITALIZED AND ADMINISTERED ANTIBIOTIC TREATMENT. THE S-ICD REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410121 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010

    Patients

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