BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 3901961 · Received May 7, 2014

    Report

    Report Number
    3009448963-2014-00055
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    January 7, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE, 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 AT THE IMPLANT OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM INDUCTION TESTING WAS PERFORMED AND THERE WAS NON-CONVERSION AT 65 JOULES IN BOTH STANDARD AND REVERSE POLARITY. SUBSEQUENTLY, THE DEVICE WAS REPOSITIONED MORE POSTERIORLY. WHEN ATTEMPTING TO DO AUTO SET-UP, AN OPTIMAL VECTOR WAS UNABLE TO BE IDENTIFIED AND PRIMARY 2X WAS MANUALLY CHOSE. INDUCTION WAS REPEATED WITH SUCCESSFUL CONVERSION AT 65 JOULES STANDARD POLARITY. UPON FOLLOW-UP EVALUATION IN THE RECOVERY ROOM AND THE NEXT DAY, AUTO SET-UP WAS SUCCESSFUL WITH THE DEVICE CHOOSING SECONDARY 1X. THE SENSING VECTOR WAS REPROGRAMMED AND THE INFORMATION WAS DISCUSSED WITH THE PHYSICIAN. THE PLAN WAS TO RE-EVALUATE IN TWO WEEKS. HOWEVER, THREE DAYS LATER THE PATIENT WAS BEING TRANSPORTED HOME BY AMBULANCE, AND RECEIVED MULTIPLE INAPPROPRIATE SHOCKS DUE TO NOISE. THERAPY WAS NOT EXHAUSTED. ISOMETRICS WITH LEFT ARM ACROSS THE CHEST PRODUCED NOISE IN THE SECONDARY AND ALTERNATE VECTORS, NO NOISE WAS NOTED ON THE PRIMARY VECTOR AOR WITH PRESSING ON THE DEVICE POCKET. NOISE WAS ALSO REPEATEDLY REPRODUCED BY PINCHING THE SKIN NEAR THE DISTAL TIP (STERNAL) INCISION AND WITH TUGGING ON THE BANDAGE. DISCUSSIONS TOOK PLACE REGARDING X-RAY RESULTS AND ELECTRODE POSITON AND POTENTIAL REASONS FOR THE OBSERVATION WERE REVIEWED, AS WELL AS , TREATMENT OPTIONS. ON X-RAY THE PHYSICIAN VISUALIZED AIR AT THE DISTAL END OF THE ELECTRODE ULTIMATELY THE SENSING VECTOR OF PRIMARY 2X WAS PROGRAMMED AND THE PATIENT UNDERWENT A DOPAMINE STRESS TEST TO EVALUATE THE SYSTEM AT HIGHER HEART RATES. THE FIELD REPRESENTATIVE REPORTED THAT THERE WAS NO OVERSENSING OR DOUBLE COUNTING OF T-WAVES DURING THE TEST. A FOLLOW-UP APPOINTMENT WAS SCHEDULED FOR EARLY NEXT MONTH. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276824 S-ICD SYSTEM IMPLANTABLE LEAD NVY CAMERON HEALTH INC 3010

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR 1010