BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 3850563 · Received May 22, 2014

    Report

    Report Number
    3009448963-2014-00093
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    NVY
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE, 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 TWO WEEKS POST SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) IMPLANT, THE PATIENT WAS SEEN AND THE WOUND SHOWED APPROPRIATE HEALING AND NO SIGNS OF INFECTION. THEN, AT FOUR WEEKS AFTER IMPLANT, THE PATIENT PRESENTED WITH AN OPEN WOUND AND DRAINING. THE SYSTEM WAS SUBSEQUENTLY EXPLANTED. IT WAS REPORTED THAT PREVIOUSLY THE PATIENT HAD THREE OTHER NON-BOSTON SCIENTIFIC DEVICE IMPLANTS THAT WERE ALSO EXPLANTED DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306920 S-ICD SYSTEM IMPLANTABLE LEAD NVY CAMERON HEALTH 3010

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R 1010