BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 6109282 · Received November 17, 2016

    Report

    Report Number
    3007566237-2016-04111
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Report Date
    November 17, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING STIMULATION THAT IS CUTTING IN AND OUT. THE CONTACT STATED THAT ONE LEAD HAS AN IMPEDANCE ISSUE, HAVING IMPEDANCE VALUES OVER 10000 OHMS. THE PATIENT WAS REPROGRAMMED TO USE THE LEAD WITHOUT IMPEDANCE ISSUES, BUT THE PATIENT WAS STILL EXPERIENCING INTERMITTENT STIMULATION. THE ISSUES ARE STILL EXPERIENCED WHEN THE PATIENT IS NOT MOVING, AND THE PATIENT LOST STIMULATION JUST STANDING THERE. THE REPRESENTATIVE WAS DIRECTED TO PALPATE ALONG THE SYSTEM WHEN STIMULATION IS PRESENT AND OBTAIN AN X-RAY TO CHECK FOR POSSIBLE SYSTEM DAMAGE. THE PATIENT NOTED THAT THE SAME ISSUES HAVE OCCURRED 4-5 TIMES IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760811 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1