BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITATRON DA+ T-SERIES DR

    MDR report key: 3155584 · Received June 8, 2013

    Report

    Report Number
    6000095-2013-00013
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    VITATRON MEDICAL B.V.
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Removal / Correction Number
    Z-1000-2007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCT: 43007, COMPETITOR IMPLANTABLE PACING LEAD, (B)(6) 1999. (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. 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. THERE WAS A FLIPPED BIT IN THE RAWWARE. THE DEVICE FULLY RECOVERED AFTER THE RESET.

    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 THE DEVICE HAD A POWER ON RESET DUE TO A FLIPPED BIT. THE DEVICE WAS REPROGRAMMED AND 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
    255277 VITATRON DA+ T-SERIES DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY VITATRON MEDICAL B.V. T60A1B

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention 4037 IMPLANTABLE PACING LEAD