BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVITRAX

    MDR report key: 2810556 · Received October 31, 2012

    Report

    Report Number
    2647346-2012-01752
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P850051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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) - THE DEVICE WAS RETURNED, ANALYZED AND ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) DUE TO NO PACING OUTPUT ON THE DEVICE. THE PATIENT HAS NOT HAD A DEVICE CHECK IN YEARS. 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 ACTIVITRAX IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. 8400

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R 6901 IMPLANTABLE PACING LEAD| 5866 IMPLANTABLE LEAD ADAPTOR