BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA+ C SERIES SR

    MDR report key: 2053390 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05893
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 1, 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
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 WHEN THE DEVICE WAS INTERROGATED AN ERROR MESSAGE DISPLAYED. AN ATTEMPT WAS MADE TO INTERROGATE THE DEVICE WITH TWO PROGRAMMERS. A POWER ON RESET WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DEVICE WAS INTERROGATED AN ERROR MESSAGE DISPLAYED. AN ATTEMPT WAS MADE TO INTERROGATE THE DEVICE WITH TWO PROGRAMMERS. A POWER ON RESET WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND 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 SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. C20A3 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R