BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD GENERAL

    MDR report key: 2100714 · Received May 12, 2011

    Report

    Report Number
    3007566237-2011-03445
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    January 1, 2009
    Report Date
    January 19, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REC'D INFO THE PHYSICIAN FEELS THE NEEDLE GAUGE IS TOO THIN CAUSING IT TO BREAK. HE WOULD LIKE TO SEE A LONGER NEEDLE INCLUDED IN THE TRIAL KIT - THE 25 GAUGE NEEDLE HAS BROKEN WHEN BENDING DURING INSERTION. CURRENTLY, THE KIT INCLUDES A 1IN 25GA NEEDLE. THE PHYSICIAN WOULD LIKE TO HAVE A 2IN NEEDLE. THE PHYSICIAN WOULD LIKE THE NEEDLE TO BE 22GA SINCE HE LIKES TO BEND IT AND THE 25GA NEEDLE HAS BROKEN ON HIM WHEN HE DID THIS. HE BENDS THE NEEDLE TO MORE EASILY INJECT UNDER THE SKIN IN A WIDE CIRCLE RATHER THAN FROM A SINGLE CENTRAL INJECTION SITE. HE BELIEVES THIS IS LESS PAINFUL TO THE PT THAN MULTIPLE STRAIGHT IN STICKS.

    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