BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA+ C SERIES DR

    MDR report key: 2053142 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05783
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    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.

    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. CORRECTION: INITIAL REPORT SUBMITTED ON (B)(6) 2011 REFLECTED THE INCORRECT MANUFACTURING SITE. THEREFORE, A SUPPLEMENTAL REPORT IS BEING SUBMITTED TO INDICATE THE CORRECT MANUFACTURING SITE AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION OF THE DEVICE AN ERROR MESSAGE OCCURRED INDICATING THE DEVICE HAD "TRIGGERED THE BACKUP MODE". THE DEVICE RESTORED ITSELF SUCCESSFULLY AND REMAINS 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. C60A2 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other