BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 4182082 · Received October 17, 2014

    Report

    Report Number
    6000153-2014-00180
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    August 12, 2014
    Manufacturer
    NEURO - VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF LEAD (L/N VA0KK9J), FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRIAL IMPLANT, THE HEALTHCARE PROFESSIONAL (HCP) WAS NOT ABLE TO STEER THE LEAD AND THE LEAD DID NOT RESPOND. IT WAS STATED THAT THE LEAD WAS NEVER IMPLANTED AND HAD BEEN RETURNED. IT WAS STATED THAT THE LEAD WAS REPLACED BY ANOTHER PRODUCT BY THE SAME MANUFACTURER. IT WAS NOTED THAT THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY AND THERE WERE NO ASSOCIATED SYMPTOMS OR COMPLICATIONS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE TRIAL LEAD WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. IT WAS NOTED THAT THERE HAD BEEN POSITIONING DIFFICULTY WHEN THE HCP HAD NOT BEEN ABLE TO STEER/MANEUVER THE LEAD. IT WAS NOTED THAT THERE WAS NO PATIENT DEATH OR INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660750 N/A STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW NEURO - VILLALBA 387360 VA0KK9J

    Patients

    Seq Age Sex Outcome Treatment
    1