BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 3252170 · Received July 25, 2013

    Report

    Report Number
    3009448963-2013-00086
    Event Type
    Injury
    Date Received
    July 25, 2013
    Date of Event
    July 18, 2013
    Report Date
    July 18, 2013
    Manufacturer
    CAMERON HEALTH
    Product Code
    NVY
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 THE ELECTRODE INCISION SITE POST-IMPLANT, CONTINUED TO BE A SOURCE OF INFECTION. ORAL ANTIBIOTIC WERE ADMINISTERED HOWEVER THE INFECTION REMAINED UNRESOLVED. AS A RESULT, THE PHYSICIAN ELECTED TO SURGICALLY INTERVENE AND EXPLANT BOTH THE ELECTRODE AND THE ASSOCIATED DEVICE. NO ADVERSE PT EFFECTS WERE REPORTED AND NO RETURN OF PRODUCT IS EXPECTED. OTHER SYSTEM WOULD BE DISCUSSED FOR IMPLANT AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347942 S-ICD SYSTEM IMPLANTABLE LEAD NVY CAMERON HEALTH 3010

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R 1010| 3400