BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERA-I VDD

    MDR report key: 1855238 · Received October 6, 2010

    Report

    Report Number
    2647346-2010-00570
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    August 26, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S39
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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): BATTERY DEPLETION WAS FOUND TO BE NORMAL, HOWEVER THE SET SCREW WAS FOUND TO HAVE A ROUNDED SOCKET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXPERIENCED NORMAL BATTERY DEPLETION AND WAS BEING REPLACED. THE PHYSICIAN HAD DIFFICULTY DISCONNECTING THE DEVICE AND NOTED THE SET SCREWS FOR THE DEVICE CONNECTOR WERE STRIPPED. 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 VDD ASKU DXY MEDTRONIC MED REL, INC. 8968IB ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention 5038 IMPLANTABLE PACING LEAD| 5038 IMPLANTABLE PACING LEAD