BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERA-I SR

    MDR report key: 1863243 · Received October 9, 2010

    Report

    Report Number
    2647346-2010-00643
    Event Type
    Injury
    Date Received
    October 9, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S37
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. IT WAS ALSO REPORTED THAT THE LEAD IMPEDANCE HAD DECREASED SINCE IMPLANT. THE LEAD WAS CAPPED AND REPLACED, AND 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 THERA-I SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. 8960IB ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention