BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD GENERAL

    MDR report key: 2100709 · Received May 12, 2011

    Report

    Report Number
    3007566237-2011-03446
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    May 1, 2009
    Report Date
    April 7, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REC'D INFO FROM PHYSICIAN THAT SHE OVER-ADVANCES THE LEAD TO MITIGATE MIGRATION ISSUES. FEELS THE LEAD IS PRONE TO MIGRATION. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD GENERAL EZW MEDTRONIC NEUROMODULATION LEAD URO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| EXTENSION: MODEL EXTENSION LOT# UNKNOWN| EXPLANTED: