BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911385 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15798
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 22, 2012
    Report Date
    November 22, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 WHEN PERFORMING AN ABLATION PROCEDURE, THE TACHY MODE WAS PROGRAMMED OFF; HOWEVER, SOME PACING INHIBITION WAS NOTED. AS THE PATIENT WAS PACING DEPENDENT, THE DEVICE WAS PROGRAMMED TO ELECTROCAUTERY MODE. THE PROCEDURE WAS PERFORMED; HOWEVER, DESPITE BEING PROGRAMMED IN DOO MODE, PERIODS OF ASYSTOLE WERE NOTED. IT WAS CONFIRMED THE PRE-PROCEDURE AND POST-PROCEDURE CHECKS WERE NORMAL AND THE DEVICE WAS FUNCTIONING APPROPRIATELY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT ELECTROMAGNETIC INTERFERENCE (EMI) GENERATED BY RADIO FREQUENCY CURRENT IN CLOSE PROXIMITY TO THE LEAD TIP COULD ALTER THE PACING SPIKE. ADDITIONALLY, THE RADIO FREQUENCY COULD AFFECT THE TISSUE PERFORMANCE OR HEART CONDUCTION PATHWAYS SURROUNDING THE LEAD TIP. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17362 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1