BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4193523 · Received August 6, 2014

    Report

    Report Number
    3009448963-2014-00168
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 8, 2014
    Manufacturer
    CAMERON HEALTH INC.
    Product Code
    NVY
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    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 THE PATIENT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM DEVELOPED A HEMATOMA APPROXIMATELY ONE WEEK AFTER IMPLANT. BLOOD WORK WAS DONE AND THE PATIENT'S WHITE COUNT WAS OKAY SO THE PATIENT WAS SENT HOME. A WEEK ALTER THE PATIENT WAS RE-REEVALUATED DUE TO POCKET PAIN, REDNESS, AND SWELLING; THE STERNAL INCISIONS LOOKED FINE. THE PATIENT TESTED POSITIVE FOR STAPH INFECTION AND IV ANTIBIOTICS WERE INITIATED. THE PLAN WAS TO REEVALUATE AFTER A FEW DAYS. FURTHER INFORMATION WAS RECEIVED THAT THE SYSTEM WAS SUBSEQUENTLY EXPLANTED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. IT WAS INDICATED THAT THIS PRODUCT WOULD NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461527 S-ICD SYSTEM IMPLANTABLE LEAD NVY CAMERON HEALTH INC. 3010

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R 1010