BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4152427 · Received June 26, 2014

    Report

    Report Number
    3009448963-2014-00135
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 16, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM WAS POSSIBLY ERODING THROUGH THE SKIN. THE PT CAME IN TO THE CLINIC, BUT THERE WAS NO SIGN OF POCKET EROSION SO NO INTERVENTIONS WERE TAKEN. APPROX TWO WEEKS LATER, THE PT PRESENTED TO THE HOSPITAL DUE TO DRAINAGE AT THE POCKET INCISION. NO CULTURES WERE TAKEN, BUT THE PHYSICIAN DEBRIDED THE POCKET AND THEN CLOSED IT WITHOUT INCIDENT. THE FIELD REP WAS NOT AWARE IF THE PT RECEIVED ANTIBIOTICS. THE S-ICD SYSTEM REMAINS IN SERVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373238 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening| R 3010