BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 4232386 · Received August 26, 2014

    Report

    Report Number
    3009448963-2014-00194
    Event Type
    Malfunction
    Date Received
    August 26, 2014
    Date of Event
    July 23, 2014
    Report Date
    August 5, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    NVY
    PMA / PMN Number
    P11042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 THIS LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC AND TECHNICAL SERVICES (TS). THIS PATIENT RECEIVED AN INAPPROPRIATE SHOCK APPROXIMATELY 2-3 HOURS AFTER THE IMPLANT PROCEDURE WHILE LYING IN THE HOSPITAL BED. A REVIEW OF THE EPISODE IDENTIFIED A WANDERING BASELINE ASSOCIATED WITH SMALL QRS AMPLITUDE RESULTING IN OVERSENSING. THESE SIGNAL CHANGES WERE OBSERVED ON THE PRIMARY SENSE VECTOR (SENSE B TO CAN). THERE WAS NO ELECTROGRAM NOISE ON THE SECONDARY SENSE VECTOR. TS DISCUSSED THE POSSIBILITY OF AIR POCKETS NEAR THE SENSE B ELECTRODE AND/OR POSSIBLE UNDER INSERTION OF THE LEAD INTO THE DEVICE. TS SUGGESTED THE PHYSICIAN OBTAIN PA AND LATERAL CHEST X-RAYS OF THE SENSE B ELECTRODE SITE FOR POSSIBLE AIR POCKETS. ADDITIONALLY, THE PHYSICIAN COULD MANIPULATE THE SITE OF THE XYPHOID/SENSE B INCISION TO OBSERVE ANY SIGNAL CHANGES. A SHOCK IMPEDANCE OF 67 OHMS INDICATED GOOD CONNECTION TO THE SHOCK ELECTRODE FROM THE DEVICE. TS SUGGESTED THE OPTION OF REPROGRAMMING THE SENSE VECTOR TO SECONDARY TO AVOID USING THE SENSE B ELECTRODE. AN AIR-RELATED ISSUE SHOULD RESOLVE AND THE DEVICE SENSE VECTOR COULD BE REPROGRAMMED BACK TO PRIMARY. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE DEVICE SENSE VECTOR WAS REPROGRAMMED TO SECONDARY AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE DEVICE SENSE VECTORS WILL BE CHECKED AGAIN AT THE NEXT IN-CLINIC FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515557 S-ICD SYSTEM IMPLANTABLE LEAD NVY CAMERON HEALTH 3010

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR 1010