BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA+ C SERIES DR

    MDR report key: 2812661 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02610
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    August 13, 2012
    Report Date
    February 13, 2013
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY (B)(4) THE ACTUAL PRODUCT WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND ANALYZED THE DATA. THE SAVE TO DISK PRIMARY FINDING NOTED THAT THE DEVICE HAD A FULL POWER ON RESET (POR). STARVATION OF HALL SENSOR CAUSED POR. PROGRAMMED PARAMETERS WERE RESTORED FROM BACKUP EEPROM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A POWER ON RESET. THE DEVICE SETTINGS WERE RESTORED AND THE DEVICE 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
    1 DA+ C SERIES DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC S.A. C60A2

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention