BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITATRON DA+ T-SERIES DR

    MDR report key: 2953323 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00232
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED A PARTIAL ELECTRICAL RESET.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF HIGH RATES. THE DEVICE WAS INTERROGATED AND FOUND TO BE IN DDD MODE AND WAS PACING AROUND 105 BPM BUT IT WAS PROGRAMMED AT A RATE 70 BPM. THE PHYSICIAN REPROGRAMMED THE DEVICE AND TEMPORARILY PROGRAMMED THE DEVICE TO 40 BMP BUT THE DEVICE WAS STILL PACING AROUND 70 BPM AND THE R WAVES COULD NOT BE MEASURED. A REVIEW OF THE DEVICE PERFORMANCE INFORMATION INDICATED THAT THE DEVICE EXPERIENCED A BIT FLIP AND WAS IN NEED OF A MANUAL GUIDED RESET (MGR). THE MGR WAS PERFORMED AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57309 VITATRON DA+ T-SERIES DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY IPG MFG SWITZERLAND T70A1U

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention