BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4152431 · Received July 31, 2014

    Report

    Report Number
    3009448963-2014-00162
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    NVY
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 ELECTIVE DEFIBRILLATION THRESHOLD (DFT) TESTING WAS GOING TO BE PERFORMED ON THE PT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM. ON FLUOROSCOPY EVAL IT WAS NOTED THE ELECTRODE HAD MOVED FROM ITS ORIGINAL POSITION. THEREFORE, A REVISION PROCEDURE WAS DONE AND WHEN THE XYPHOID INCISION WAS OPENED IT WAS OBSERVED THAT THE SUTURE SLEEVE WAS FRACTURED; A THIRD OF THE SUTURE SLEEVE WAS NOT ATTACHED TO THE ELECTRODE AND THE OTHER WAS STILL ATTACHED BUT WAS OVER THE SENSING ELECTRODE. THE SUTURE SLEEVE WAS REPLACED AND THE ELECTRODE WAS REPOSITIONED. THE DEVICE WAS ALSO REPOSITIONED TO A MORE FASCIAL LINE AT THIS TIME. NO DFT TESTING WAS COMPLETED AS THE PT WAS NOT INDUCIBLE. NO ADVERSE PT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IN SERVICE. THE SUTURE SLEEVE WAS RETURNED TO BOSTON SCIENTIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447375 S-ICD SYSTEM IMPLANTABLE LEAD NVY CAMERON HEALTH 3010

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R 1010