BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3874 1X8 COMPACT TRIAL LEAD

    MDR report key: 2941306 · Received February 4, 2013

    Report

    Report Number
    6000153-2013-00009
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    January 11, 2013
    Manufacturer
    NEURO - VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_ENS_STIMULATOR, SERIAL # UNKNOWN, PRODUCT TYPE EXTERNAL NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STYLET STUCK DURING INSERTION. THE STYLET COULD NOT BE RE-INSERTED. THE LEAD LOOKED KINKED AND "FLATTENED LOOKING ABOVE CONTACTS ON THE LEAD." THREE WEEKS LATER IT WAS REPORTED THAT THE PATIENT WAS FINE AND HAD NO NEGATIVE EXPERIENCE. NEW LEAD WAS TRIED IMMEDIATELY AND HE HAD A POSITIVE TRIAL. THE PATIENT WAS WAITING TO BE IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE LEAD WAS NOT RETURNED FOR ANALYSIS, AS IT COULD NOT BE LOCATED. IT WAS STATED THE PATIENT SUFFERED NO ILL EFFECT AS THE PATIENT'S LEAD WAS IMMEDIATELY SWITCHED. IT WAS NOTED THE PATIENT HAD A POSITIVE TRIAL AND THAT "ALL WAS WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47151 3874 1X8 COMPACT TRIAL LEAD STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW NEURO - VILLALBA 3874 VA05MDC

    Patients

    Seq Age Sex Outcome Treatment
    1