BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 3901984 · Received May 7, 2014

    Report

    Report Number
    3009448963-2014-00050
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    June 22, 2012
    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
    NZ
    Reporter Occupation
    PHYSICIAN

    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 THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AND ELECTRODE WERE IMPLANTED WITHOUT ANY COMPLICATIONS. INDUCTION TESTING WAS PERFORMED AND THE SYSTEM SUCCESSFULLY TERMINATED THE INDUCED ARRHYTHMIA. ALL MEASUREMENTS WERE IN NORMAL RANGE. DURING PRE-DISCHARGE TESTING OF THE SYSTEM, AN ARTIFACT WAS OBSERVED ON THE ELECTROGRAM. THE DATA WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS FURTHER EVALUATION. THE ENGINEERING TEAM REVIEWED THE ARTIFACT AND DISCUSSED THAT IT WAS POSSIBLY A RESULT OF A RESIDUAL ENERGY FIELD THAT HAD FORMED AROUND THE ELECTRODE COIL AFTER THE SHOCK DELIVERY. THE DEVICE WAS PROGRAMMED TO AN APPROPRIATE SENSING VECTOR WHERE THE ARTIFACT WAS NOT OBSERVED. THERE HAVE BEEN NO FURTHER SENSING ISSUES NOTED SINCE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE ELECTRODE AND S-ICD REMAIN IMPLANTED AND IN SERVICE. ADDITIONAL INFORMATION WAS LATER REPORTED THAT THE S-ICD AND ELECTRODE WERE EXPLANTED AS A RESULT OF AN INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS INFECTION INFORMATION IS REFERENCED IN MDR REPORT 3009448963-2013-00080 AND 3009448963-2013-00081. THE ELECTRODE AND S-ICD WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276763 S-ICD SYSTEM IMPLANTABLE LEAD NVY CAMERON HEALTH INC 3010

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR (B)(4)