BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA+ T SERIES DR

    MDR report key: 2811905 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02523
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. PRELIMINARY ANALYSIS REVEALED DEVICE INTEGRATED CIRCUIT MEMORY ERROR.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 SAME TO A DEVICE MARKETED IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED. A NOTIFICATION MESSAGE APPEARED ON THE PROGRAMMER STATING IT DID NOT HAVE THE RIGHT SOFTWARE. MULTIPLE PROGRAMMERS WERE TESTED ON THE DEVICE WITHOUT SUCCESS. EARLY BATTERY DEPLETION WAS QUESTIONED. DEVICE DATA REVEALED THERE WAS BIT FLIP WHICH CAUSED THE SOFTWARE TO NOT RECOGNIZE THE DEVICE AND DISPLAYED THE MESSAGE. THE DEVICE WAS EXPLANTED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA+ T SERIES DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. T70A1

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R