BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AT500

    MDR report key: 2053436 · Received April 13, 2011

    Report

    Report Number
    6000094-2011-00540
    Event Type
    Injury
    Date Received
    April 13, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S013
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY FOR (B)(4): BATTERY - BATTERY DEPLETION-NORMAL. THE NO OUTPUT AND NO TELEMETRY CONDITIONS WERE THE RESULT OF BATTERY DEPLETION. BOTH LOADED AND UNLOADED PACING CURRENT DRAIN LEVELS WERE NORMAL FOR THIS DEVICE AT BOL (BEGINNING OF LIFE) VOLTAGES. WITHOUT KNOWING THE COMPLETE PROGRAMMING HISTORY OF THIS DEVICE THERE IS NO WAY TO ACCURATELY DETERMINE THE LONGEVITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME INTO THE CLINIC AFTER COMPLAINING OF BEING SYMPTOMATIC. IN THE CLINIC, THE DEVICE COULD NOT BE INTERROGATED AND A TEMPORARY PACING WIRE WAS NEEDED. 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 AT500 IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. AT501 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R