BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4170567 · Received October 9, 2014

    Report

    Report Number
    3009448963-2014-00257
    Event Type
    Injury
    Date Received
    October 9, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    NVY
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 SHORTLY AFTER THE IMPLANT PROCEDURE OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AND ELECTRODE, THE PATIENT EXPERIENCED A HEMATOMA. IT WAS OBSERVED THAT THE PATIENT'S SKIN WAS VERY THIN, AND THE PHYSICIAN ELECTED TO REVISE THE DEVICE POCKET TO MOVE THE DEVICE TO A DEEPER POSITION. WHEN THE POCKET WAS OPENED, A SUSPICIOUS INFECTIOUS LIQUID WAS OBSERVED. ALTHOUGH THE CULTURE ANALYSIS WAS NEGATIVE, THE SYSTEM WAS EXPLANTED AND THE PATIENT WAS TREATED FOR INFECTION. IT WAS PLANNED TO IMPLANT A NEW S-ICD SYSTEM AFTER THE SUSPECTED INFECTION WAS CLEARED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636875 S-ICD SYSTEM IMPLANTABLE LEAD NVY CAMERON HEALTH 3010

    Patients

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