BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA+ C SERIES DR

    MDR report key: 2791197 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15416
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 25, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT CAME IN FOR A ROUTINE FOLLOW-UP THEY WERE HAVING DIFFICULTY INTERROGATING THE IMPLANTABLE PULSE GENERATOR (IPG). THE PROGRAMMER STARTS INTERROGATING WHEN THE SCREEN COMES TO INTERROGATION COMPLETE, THE SCREEN GOES BLANK AND A MESSAGE COMES UP ON THE SCREEN OF PROGRAMMER. THEY WERE ABLE TO OBTAIN INFORMATION WITH A MAGNET OVER THE DEVICE. IT APPEARS THERE MAY BE A FLIPPED BIT IN THE DEVICE PROGRAMMING. THE DEVICE REMAINS IN USE AND 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+ C SERIES DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC PUERTO RICO, INC. C50A3

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other