BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 2335062 · Received November 14, 2011

    Report

    Report Number
    6000153-2011-08925
    Event Type
    Malfunction
    Date Received
    November 14, 2011
    Date of Event
    October 4, 2011
    Report Date
    October 19, 2011
    Manufacturer
    NEURO - VILLABA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF LEAD MODEL 3778-45 SERIAL# (B)(4) SHOWED CIRCUIT #1 WAS BROKEN AT THE #1 ELECTRODE. THE INSULATION WAS BROKEN/TORN UNDER ELECTRODE #1. LAB FUNCTIONAL TESTING SHOWED AN OPEN CIRCUIT AT CIRCUIT #1, NO SHORTS AND ACCEPTABLE CONTINUITY AT CIRCUITS #0, 2 THROUGH 7.

    Additional Manufacturer Narrative · 1

    THE LEAD HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE HEALTH CARE PROFESSIONAL TRIED TO BEND THE STYLET MORE FOR STEARING ABILITY WHILE IT WAS INSIDE THE LEAD, AND THE LEAD BROKE AT ELECTRODE #1. THE LEAD WAS NOT IMPLANTED, AND A NEW LEAD WAS USED. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NEURO - VILLABA 3778-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR