BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 3901941 · Received May 7, 2014

    Report

    Report Number
    3009448963-2014-00057
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    January 24, 2014
    Report Date
    April 9, 2014
    Manufacturer
    CAMERON HEALTH INC
    Product Code
    NVY
    PMA / PMN Number
    P11042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE S-ICD DELIVERED AN INAPPROPRIATE SHOCK POST-IMPLANT WHILE THE PATIENT WAS GETTING IN TO BED IN RECOVERY. NOISE WAS RECREATED WITH XIPHOID MANIPULATION IN BOTH PRIMARY AND ALTERNATE VECTORS. SPECULATION AT THIS TIME WA AIR IN THE XIPHOID INCISION. SECONDARY VECTOR WAS PROGRAMMED TO A GAIN OF X2. X-RAYS WERE TAKEN FOR REVIEW. NO ADVERSE PATIENT EFFECTS WERE REPORTED. X-RAY WERE REVIEWED BY A BOSTON SCIENTIFIC ENGINEER. THE ELECTRODE APPEARED MUCH MORE LEFT LATERAL (TOWARD PULSE GENERATOR) THAN EXPECTED. IT WAS NOTED THE X-RAYS WERE TAKEN BEDSIDE ON THE DAY OF THE IMPLANT PROCEDURE AND THE PATIENT MAY HAVE BEEN AN ANGLE, WHICH SOMEWHAT EXAGGERATED THE SYSTEM POSITION TOWARD THE LEFT. IT WAS DIFFICULT FOR THE ENGINEER TO INTERPRET IF THERE WAS ANY AIR AROUND THE ELECTRODE WITH THIS VIEW. ANOTHER X-RAY WAS TAKEN ONE DAY POST-IMPLANT WHICH SHOWS THE "TRUE" POSITION OF THIS SYSTEM AS MORE MEDIAL, ABOVE THE STERNUM. THE ELECTRODE APPEARED TO BE IN A RELATIVELY TYPICAL IMPLANT POSITION. THE PULSE GENERATOR WAS ALSO IN TYPICAL IMPLANT POSITION, MAYBE SLIGHTLY ANTERIOR. NO FURTHER EVALUATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276867 S-ICD SYSTEM IMPLANTABLE LEAD NVY CAMERON HEALTH INC 3010

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR 1010