BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERA-I DR

    MDR report key: 1926314 · Received December 14, 2010

    Report

    Report Number
    2647346-2010-00877
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 12, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S37
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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: (B)(4) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED AND THE DEVICE WAS AT THE END OF ITS OPERATIONAL LIFETIME. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERA-I DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. 7960IB ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R 4068 IMPLANTABLE PACING LEAD| 4092 IMPLANTABLE PACING LEAD