BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4181359 · Received August 14, 2014

    Report

    Report Number
    3009448963-2014-00183
    Event Type
    Injury
    Date Received
    August 14, 2014
    Date of Event
    July 23, 2014
    Report Date
    February 26, 2018
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    UDI-DI
    00802526562815
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IN SERVICE WITHOUT FURTHER COMPLICATION. AS NO FURTHER INFO CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFO BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT AFTER THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS IMPLANTED, THE PT SUFFERED EXCESSIVE BLEEDING. IT WAS NOTED THAT THE PT'S BLOOD CLOTTING FACTOR WAS INSUFFICIENT. AN INTERVENTION WAS PERFORMED TO INVESTIGATE THE CAUSE OF THE BLEEDING; ELECTROCAUTERY WAS THEN USED TO STEM THE BLEEDING AND THE PT RECEIVED FIVE UNITS OF BLOOD. NO ADDITIONAL ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484923 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010 A011199 00802526562815

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| H| R 3010.| 3010.| (B)(4)