BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2821413 · Received November 6, 2012

    Report

    Report Number
    3007566237-2012-02631
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    October 8, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT IMPEDANCE MEASUREMENTS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) WERE NORMAL. THE DEVICE WAS REPROGRAMMED BY THE MANUFACTURER'S REPRESENTATIVE AND THE PATIENT HAD "GOOD RESULTS". IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION WHEN SHE WAS IN A RECLINED POSITION. THE PATIENT DESCRIBED THE SHOCK AS "THE KIND OF SHOCK THAT TAKES YOUR BREATH AWAY." IT TOOK THE PATIENT AWHILE TO TURN OFF THE STIMULATION AND ONCE IT WAS OFF IT REPORTEDLY TOOK "SOME TIME" FOR THE STIMULATION TO FADE AWAY. IT WAS FURTHER REPORTED THAT SINCE THE SHOCKING INCIDENT THE PATIENT HAS HAD SOME TENDERNESS ON THE LEFT FLANK SIDE WHERE THE SUBCUTANEOUS LEADS ARE LOCATED. IT WAS ALSO NOTED THAT THE BINDER WAS HURTING THE PATIENT'S SIDE. THE MANUFACTURE REPRESENTATIVE TURNED THE STIMULATION ON BUT THE PATIENT STARTED TO REPORT "SHOCKING/ UNCOMFORTABLE SENSATION" ON THE LEFT BUTTOCK AREA BUT IT SUBSIDED A FEW MINUTES LATER AFTER STIMULATION WAS TURNED OFF. IT WAS UNCERTAIN WHETHER THIS WAS RELATED TO THE STIMULATION OR IF IT WAS THE "NORMAL "SHOCKING" SENSATION" THE PATIENT TYPICALLY HAS WITHOUT STIMULATION. IT WAS ALSO REPORTED THAT THE PATIENT "FELT LIKE THE LEAD AT THE SUBCUTANEOUS PLACEMENT WAS PUSHING OUT OF THE SKIN," HOWEVER THE MANUFACTURE REPRESENTATIVE COULD NOT SEE THAT. CURRENT AND IMPEDANCE MEASUREMENTS WERE NORMAL AT 1200-1600 OHMS AND THE PATIENT WAS AT 1.4 VOLTS FOR THE SPINAL LEAD AND .7 VOLTS FOR THE SUBCUTANEOUS LEADS. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37712

    Patients

    Seq Age Sex Outcome Treatment
    1