BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4181338 · Received August 7, 2014

    Report

    Report Number
    3009448963-2014-00169
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFO CONCERNING THIS REPORT IS CURRENTLY AVAILABLE, 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 THIS PT UNDERWENT A LEAD EXTRACTION JUST PRIOR TO THE IMPLANT OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM FOR WHICH THE PHYSICIAN USED A TWO INCISION TECHNIQUE. THE PT HAD A HISTORY OF NON-ISCHEMIC CARDIOMYOPATHY, RENAL ISSUES, DIABETES, HYPERTENSION, AND ON THE DAY OF THE PROCEDURE HAD HIGH POTASSIUM LEVELS. AT THE END OF THE IMPLANT THE PT WENT INTO FLASH PULMONARY EDEMA, AND AS THE ANESTHESIOLOGIST WAS INTUBATING PT AN INAPPROPRIATE SHOCK WAS DELIVERED DUE TO NOISE. POTENTIAL REASONS THAT THE NOISE MAY HAVE OCCURRED WERE REVIEWED. DEFIBRILLATION THRESHOLD (DFT) TEST WAS NOT PERFORMED DUE TO THE PT'S HEALTH CONDITION. THE S-ICD WAS RE-OPTIMIZED IN THE RECOVERY ROOM WHERE A DIFFERENT SENSING VECTOR WAS SELECTED AND PROGRAMMED. A CHEST X-RAY WAS TAKEN AS WELL, BUT RESULTS WERE NOT AVAILABLE. FURTHER EVAL WAS PLANNED AT THE TIME OF THE PT'S WOUND CHECK. THE PT WAS EXTUBATED THE DAY POST IMPLANT. NO FURTHER ADVERSE PT EFFECTS HAVE BEEN REPORTED AND THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462380 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| L| R (B)(4)