BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITATRON DA+ C-SERIES DR

    MDR report key: 3990423 · Received August 7, 2014

    Report

    Report Number
    9614453-2014-01795
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    May 6, 2012
    Report Date
    June 10, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Removal / Correction Number
    Z-0999-2007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS OF THE DEVICE MEMORY INDICATED A PARTIAL ELECTRICAL RESET. PARTIAL RESET OCCURRED ON (B)(6) 2012. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION.

    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. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED NORMAL BATTERY DEPLETION. THE RETURNED DEVICE INDICATED A FIRMWARE ERROR MESSAGE/CODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELECTRICAL RESET OCCURRED WITH THE DEVICE. THE DEVICE OPERATED IN BACK-UP MODE AND COULD NOT BE INTERROGATED. NO STIMULATION OCCURRED AND THE PATIENT EXPERIENCED FAINTING. THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND WAS SCHEDULED FOR REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464904 VITATRON DA+ C-SERIES DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY IPG MFG SWITZERLAND C60A2U

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R