BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUNCTIONAL STIMULATION

    MDR report key: 3811391 · Received May 15, 2014

    Report

    Report Number
    6000153-2014-00096
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    NEURO - VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE LEAD FOUND THAT THE BODY STYLET COIL HAD A GAP. IT WAS NOTED THAT ALL FOUR TYPES OF KNOWN GOOD STYLETS WERE TESTED WITH THE LEAD AND COULD BE INSERTED FULLY WITHOUT DIFFICULTY. IT WAS NOTED THAT THE STYLET COIL APPEARED TO HAVE BEEN SLIGHTLY DAMAGED CAUSING GAPS JUST PROXIMAL TO THE #7 ELECTRODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PLACEMENT OF LEAD FOR INITIAL IMPLANT IT WAS NOTED THAT THE STYLET WAS REMOVED AND THEY WERE UNABLE TO REPLACE THE STYLET. IT WAS NOTED THAT THE DEVICE WAS USED IN THE PATIENT. IT WAS NOTED THAT THERE WAS NO PATIENT DEATH AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290484 FUNCTIONAL STIMULATION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NEURO - VILLALBA 977A260 VA0HMGU010

    Patients

    Seq Age Sex Outcome Treatment
    1