BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERA-I SR

    MDR report key: 1555537 · Received December 10, 2009

    Report

    Report Number
    2647346-2009-00597
    Event Type
    Injury
    Date Received
    December 10, 2009
    Date of Event
    October 29, 2009
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S37
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. EVALUATION SUMMARY: ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LOSS OF OUTPUT AND THAT THE DEVICE WAS AT EOL (END OF LIFE). 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 78 YR Required Intervention 4024 IMPLANTABLE PACING LEAD