BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY DR

    MDR report key: 2022442 · Received March 17, 2011

    Report

    Report Number
    2182863-2011-00022
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2011. REVIEW OF THE PROGRAMMER FILES SHOWED THAT THE REPORTED BEHAVIOR PROBABLY RESULTED FROM COMMUNICATION INTERFERENCES. PRELIMINARY RESULTS DIDN'T REVEAL ABNORMAL FUNCTIONING OF THE DEVICE. BASED ON THE AVAILABLE INFORMATION, ABSENCE OF VENTRICULAR OUTPUT COULD BE RELATED TO AN UNINTENDED PROGRAMMING IN AAI PACING MODE. A FINAL RESPONSE FROM THE MANUFACTURER IS PENDING. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4) 2011. REVIEW OF THE PROGRAMMER FILES SHOWED THAT THE REPORTED BEHAVIOR PROBABLY RESULTED FROM COMMUNICATION INTERFERENCES. PRELIMINARY RESULTS DIDN'T REVEAL ABNORMAL FUNCTIONING OF THE DEVICE. BASED ON THE AVAILABLE INFORMATION, ABSENCE OF VENTRICULAR OUTPUT COULD BE RELATED TO AN UNINTENDED PROGRAMMING IN AAI PACING MODE. A FINAL RESPONSE FROM THE MANUFACTURER IS PENDING. (B)(4) 2011. THE DEVICE REMAINS IMPLANTED, THEREFORE, THE FILES FROM THE PROGRAMMER WERE REVIEWED. THE ABSENCE OF VENTRICULAR OUTPUT WAS PROBABLY DUE TO AN UNINTENDED PROGRAMMING IN AAI PACING MODE THAT WAS IN EFFECT FOR 9 SECONDS, AND THE MESSAGE THAT WAS DISPLAYED DURING THE INTERROGATION WITH THE SECOND PROGRAMMER RESULTED FROM TELEMETRY ERRORS LINKED TO PROBABLE COMMUNICATION INTERFERENCES. BOTH REPORTED EVENTS WERE NORMAL. NO FURTHER ACTION IS NEEDED, JUST STANDARD FOLLOW-UPS. (B)(4).

    Description of Event or Problem · 1

    POST AV NODAL ABLATION, NO PACING WAS OBSERVED ON THE ECG WHEN PROGRAMMING FROM VOO TO VII. AFTER A FEW SECONDS IT WAS PERFORMED AGAIN AND PACING WAS OBSERVED. A SECOND PROGRAMMER WAS THEN USED TO PERFORM TROUBLESHOOTING AND WHEN PROGRAMMING FROM VOO TO VII A MESSAGE WAS DISPLAYED SAYING UNABLE TO PROGRAM BIPOLAR; HOWEVER, AFTER SEVERAL ATTEMPTS BIPOLAR PACING WAS PERFORMED. THE DEVICE REMAINS IMPLANTED. FILES FROM THE PROGRAMMER WERE SENT FOR REVIEW.

    Description of Event or Problem · 1

    POST AV NODAL ABLATION, NO PACING WAS OBSERVED ON THE ECG WHEN PROGRAMMING FROM VOO TO VVI. AFTER A FEW SECONDS IT WAS PERFORMED AGAIN AND PACING WAS OBSERVED. A SECOND PROGRAMMER WAS THEN USED TO PERFORM TROUBLESHOOTING AND WHEN PROGRAMMING FROM VOO TO VVI A MESSAGE WAS DISPLAYED SAYING UNABLE TO PROGRAM BIPOLAR; HOWEVER, AFTER SEVERAL ATTEMPTS BIPOLAR SENSING WAS PROGRAMMED. THE DEVICE REMAINS IMPLANTED. FILES FROM THE PROGRAMMER WERE SENT FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY DR CARDIAC PACEMAKER DXY SORIN BIOMEDICA CRM S.R.L. REPLY DR

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR