BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD LOW IMPEDANCE LEAD

    MDR report key: 2181594 · Received July 5, 2011

    Report

    Report Number
    6000153-2011-05079
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    MPROC, VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS INSERTED INTO THE EPIDURAL SPACE WITH STRAIGHT STYLET AT FIRST, THEN THE DOCTOR TRIED TO CHANGE IT TO A CURVED STYLET TO REACH STIMULATION SPOT. HOWEVER, THE DOCTOR COULD NOT INSERT THE CURVED STYLET BECAUSE ENTRY TO THE LEAD WAS CLOGGED UP. THE DOCTOR DISCONTINUED THE LEAD AND COMPLETED THE OPERATION WITH A NEW LEAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD LOW IMPEDANCE LEAD LGW MPROC, VILLALBA 3777 V538076036

    Patients

    Seq Age Sex Outcome Treatment
    1