BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA+ C SERIES DR

    MDR report key: 2131497 · Received June 16, 2011

    Report

    Report Number
    6000094-2011-01162
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P990001/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 IN CLINIC DURING THE INTERROGATION, THE IMPLANTABLE PULSE GENERATOR GENERATED ERROR CODE ON THE PROGRAMMER SCREEN AND TRIGGERED SAFETY BACKUP PACING. THE DEVICE WAS REVERTED BACK TO PREVIOUS PACING PARAMETERS SETTINGS. THE REMAINDER OF CHECK WAS NORMAL AND PATIENT SENT BACK HOME WITH A THREE MONTH FOLLOW UP APPOINTMENT. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE 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 S.A. C60A3 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R