BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 3915186 · Received May 16, 2014

    Report

    Report Number
    3009448963-2014-00083
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    April 11, 2014
    Report Date
    May 5, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    NVY
    PMA / PMN Number
    P11042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    (B)(4) RECEIVED INFORMATION THAT THE PATIENT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM RECEIVED THREE INAPPROPRIATE SHOCKS THE NIGHT POST IMPLANT. REVIEW OF THE EPISODES SHOWED WAVY BASELINE AND OVERSENSING. THE SENSING VECTORS WERE EVALUATED AND NOISE WAS ABLE TO BE REPRODUCED WITH PALPATION AT THE XIPHOID INCISION AREA, NO NOISE WAS REPRODUCED WHEN PALPATING THE GENERATOR AREA. THE SENSING VECTOR WAS REPROGRAMMED TO EXCLUDE THE XIPHOID INCISION AREA. POTENTIAL CAUSES OF NOISE WERE DISCUSSED. X-RAY EVALUATION APPEARS TO SHOW ADEQUATE INSERTION OF THE ELECTRODE INTO THE HEADER. ELECTROMAGNETIC INTERFERENCE (EMI) MAY HAVE BEEN PRESENT, BUT THE DEVICE ACCURATELY RECOGNIZED THE NOISE AND DID NOT TREAT FOR IT. IT WAS SUSPECTED THAT THERE WAS AIR IN THE XIPHOID POCKET. SUBSEQUENT EVALUATION DONE APPROXIMATELY TWO WEEKS LATER NOTED THAT NO NOISE WAS REPRODUCIBLE AT ALL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293273 S-ICD SYSTEM IMPLANTABLE LEAD NVY CAMERON HEALTH 3010

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 1010