BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2952554 · Received February 9, 2013

    Report

    Report Number
    6000095-2013-00002
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 8, 2012
    Report Date
    November 15, 2012
    Manufacturer
    VITATRON MEDICAL B.V.
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PRODUCT PERFORMANCE DATA WAS RETURNED AND ANALYZED. A MANUAL GUIDED RESET WAS REQUESTED AND CONFIRMED TO HAVE BEEN SUCCESSFUL.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE TESTING, THE DEVICE DID NOT OPERATE AS EXPECTED. A FLIPPED BIT WAS SUSPECTED. A MANUAL GUIDED RESET WAS PERFORMED AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE TESTING, THE DEVICE DID NOT OPERATE AS EXPECTED. A FLIPPED BIT WAS SUSPECTED. A MANUAL GUIDED RESET 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
    57349 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY VITATRON MEDICAL B.V. C20A2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention