BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1316515 · Received February 18, 2009

    Report

    Report Number
    3004209178-2009-01107
    Event Type
    Malfunction
    Date Received
    February 18, 2009
    Date of Event
    January 22, 2009
    Report Date
    January 22, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT 3 A.M., THE PATIENT NO LONGER FELT STIMULATION. THE PATIENT HAD TROUBLE TURNING THE DEVICE ON AGAIN. AFTER 1/2 HOUR, HE WAS ABLE TO TURN THE STIMULATION BACK ON BUT REPORTED HE FELT A JOLTING THAT WAS AROUND A 10.5 ON A SCALE OF 1-10. THE PATIENT WAS ENCOURAGED TO CONTACT HIS HEALTHCARE PROFESSIONAL (HCP). THE NEXT DAY, THE HCP REPORTED THAT THE PATIENT FELT A SURGING OR PULSING SENSATION. FOLLOWING A POSITION CHANGE THE PATIENT DID NOT FEEL STIMULATION. IMPEDANCE MEASUREMENTS WERE TAKEN AND FOUND TO BE NORMAL WITH EXCEPTION OF ELECTRODE 3 ON THE RIGHT SIDE AND ELECTRODES 10 & 11 ON LEFT SIDE. ELECTRODE 3 WAS SHOWING A SHORT, <70 OHMS AND 35.000 MA CURRENT; ELECTRODES 10 & 11 > 3600 OHMS. THE HCP PERFORMED AN X-RAY AND STATES THAT IT LOOKED "SOMEWHAT NORMAL - THE DISTAL ENDS MIGHT BE A LITTLE CLOSE OR ALMOST TOUCHING". THE HCP STATED THE LEFT LEAD LOOKED LIKE IT WAS TOWARD THE GUTTER. REPROGRAMMING WAS ATTEMPTED, BUT IT APPEARED THAT THE PATIENT SETTINGS WERE TOO HIGH FOR GOOD THERAPY COVERAGE. THEY PLANNED TO RECHECK THE SYSTEM IN A WEEK. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other LEAD: MODEL 3487A| RECHARGER: MODEL 37752| PROGRAMMER: MODEL 37742| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION, MODEL 37083| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3487A| EXTENSION: MODEL 37083| IMPLANTED: