BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA+ C SERIES DR

    MDR report key: 1991725 · Received February 15, 2011

    Report

    Report Number
    6000094-2011-00275
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    August 20, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. DISCLAIMER: SUBMISSION OF INFORMATION BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE (S) HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY THAT MAY HAVE OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXPERIENCED A POWER ON RESET. THE DEVICE WAS EXPLANTED AND NOT REPLACED. 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 S.A. C60A2 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R