BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4823666 · Received June 4, 2015

    Report

    Report Number
    3009448963-2015-00329
    Event Type
    Injury
    Date Received
    June 4, 2015
    Date of Event
    May 29, 2015
    Report Date
    May 29, 2015
    Manufacturer
    CAMERON HEALTH INC.
    Product Code
    NVY
    UDI-DI
    00802526563201
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 FURHTER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT DEVELOPED AN INFECTION AT THE XYPHOID INCISION SITE. THE INCISION SITE WAS DRAINED AND THE PATIENT WAS GIVEN ORAL ANTIBIOTICS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHEN THE PRODUCT WAS RETURNED TO BOSTON SCIENTIFIC. THE FIELD REPRESENTATIVE WHO WAS PRESENT AT THE PRIOR PROCEDURE WAS CONTACTED TO INQUIRE WHY THE SYSTEM WAS REMOVED. SHE WAS NOT AWARE, BUT STATED SHE WOULD TRY AND FOLLOW-UP WITH THE RESEARCH COORDINATOR AT THE CLINIC. SHE WASN'T SURE IF SHE WOULD GET ANY FURTHER INFORMATION, BUT WILL ATTEMPT. THE REASON FOR THE SYSTEM EXPLANT IS NOT KNOWN TO THIS DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363788 S-ICD SYSTEM IMPLANTABLE LEAD NVY CAMERON HEALTH INC. 3010 00802526563201

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R 1010