BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AT500

    MDR report key: 2790638 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02101
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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) THE DEVICE WAS RETURNED AND ANALYZED. IT WAS REPORTED THAT THE DEVICE MET EXPECTED LONGEVITY WITH NORMAL DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TRYING TO INTERROGATE THE DEVICE, NO PACING WAS NOTED ON THE MONITOR. THE DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AT500 IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. AT501

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R 4968 IMPLANTABLE PACING LEADS X2