BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4181340 · Received August 7, 2014

    Report

    Report Number
    3009448963-2014-00172
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 21, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    NVY
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 THE PT WITH THIS DEVICE SOUGHT MEDICAL ATTENTION DUE TO AN AUDIBLE ALERT FROM THEIR IMPLANTED SYSTEM. DURING INTERROGATION, HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS WERE EXHIBITED. BOSTON SCIENTIFIC'S TECHNICAL SERVICES WAS CONTACTED FOR RECOMMENDATIONS, AS THE DEVICE IS A FAIRLY RECENT IMPLANT. NO ADVERSE EFFECTS WERE REPORTED AND ROOT CAUSE ANALYSIS REMAINED ONGOING; HOWEVER, LIKELY SUSPECTED A SETSCREW CONNECTION ANOMALY. SUBSEQUENTLY, THE PHYSICIAN ELECTED TO SURGICALLY INTERVENE. DURING INTERVENTION, A LOOSE CONNECTION WAS CONFIRMED. THE ELECTRODE'S TERMINAL PIN AND DEVICE WERE SUCCESSFULLY REESTABLISHED, WITH NO FURTHER MEASUREMENT ANOMALIES OBSERVED, POST-RECONNECTION. TO DATE THE DEVICE AND ELECTRODE REMAIN IMPLANTED AND IN SERVICE. NO ADVERSE PT EFFECTS WERE REPORTED DURING THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462400 S-ICD SYSTEM IMPLANTABLE LEAD NVY CAMERON HEALTH 3010

    Patients

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