BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA+ C SERIES DR

    MDR report key: 1924581 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06151
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PROBLEM INTERROGATING THE IMPLANTABLE PULSE GENERATOR AND THERE WAS A POWER ON RESET ERROR THAT OCCURRED. THE ERROR MESSAGE OCCURRED THREE TIMES. THE DEVICE WILL BE REPROGRAMMED. 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 MED REL, INC. C60A4 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R