BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA+ T SERIES SR

    MDR report key: 1924521 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06144
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    September 29, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P990001/S15
    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 THE DEVICE WAS UNABLE TO PERFORM ANY IMPEDANCE MEASUREMENTS THROUGH THE PROGRAMMER, WHICH DISPLAYED AN "UNABLE TO PERFORM IMPEDANCE MEASUREMENTS DUE TO AN UPDATE" MESSAGE. A MANUALLY GUIDED RESET WAS UNSUCCESSFUL IN RESOLVING THE ISSUE. THE DEVICE REMAINS IN USE; HOWEVER IT WILL BE EXPLANTED. 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+ T SERIES SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. T20A1 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R