BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4193576 · Received October 16, 2014

    Report

    Report Number
    3009448963-2014-00153
    Event Type
    Injury
    Date Received
    October 16, 2014
    Date of Event
    May 23, 2014
    Report Date
    July 10, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PT PRESENTED FOR NORMAL FOLLOW-UP OF THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM. THE S-ICD WAS IMPLANTED IN A MORE SUPERIOR POSITION TO RECRUIT MORE OF THE HEART MUSCLE DURING THERAPY, AND THUS, THE POCKET IS CLOSER TO THE LEFT AXILLA THAN USUAL. IT WAS NOTED IN THE PT'S ELECTRONIC MEDICAL RECORD CHART THAT THE HOME HEALTH SERVICE DID NOT CHANGE THE DRESSINGS FOR SEVERAL DAYS. POCKET EROSION WAS NOTED BY THE HEALTH CARE PROFESSIONAL (HCP) WITH A SMALL AMOUNT OF THE DEVICE HEADER PROTRUDING THROUGH THE SKIN. THE PHYSICIAN CLEANED AND DRESSED THE WOUND AND THE PT WAS STARTED ON ORAL ANTIBIOTICS. THE FIELD REPRESENTATIVE BELIEVED THAT STERI-STRIPS WERE USED TO ASSIST WITH INCISION HEALING. FURTHER FOLLOW-UP TO ASSESS WOUND HEALING WAS PLANNED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE WOUND CARE REMAINED SUBOPTIMAL AND THE INFECTION WORSENED. THE SYSTEM WAS THEN EXPLANTED. NO ADDITIONAL ADVERSE PT EFFECTS WERE REPORTED. THE PRODUCTS WERE RETAINED BY THE HOSPITAL AND IT IS UNK IF THEY WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658089 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| R 3010