BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 5241932 · Received November 22, 2015

    Report

    Report Number
    3009448963-2015-00637
    Event Type
    Injury
    Date Received
    November 22, 2015
    Date of Event
    November 11, 2015
    Report Date
    November 13, 2015
    Manufacturer
    CAMERON HEALTH
    Product Code
    NVY
    UDI-DI
    00802526563201
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS ERODING THROUGH THE PATIENT'S SKIN, CAUSING A RISK OF INFECTION. THIS PATIENT HAS A VERY LEAN AND ATHLETIC BODY TYPE. THERE WAS NO PUS NOTED COMING OUT OF THE POCKET AND THE PATIENT DID NOT EXPERIENCE A FEVER. THE SYSTEM WAS SUCCESSFULLY EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772032 S-ICD SYSTEM IMPLANTABLE LEAD NVY CAMERON HEALTH 3010 00802526563201

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| L| R