BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3902828 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12285
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4). THIS DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, "LOSS OF STIMULATION AND OVER STIMULATION FOR DEEP BRAIN AND SPINAL CORD STIMULATION THERAPIES", CUSTOMER LETTER (SEPTEMBER 2013).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT COULD NOT TURN STIMULATION OFF AND WAS ¿SHAKING LIKE CRAZY.¿ IT WAS NOTED THE PATIENT SAW THE ¿CALL YOUR DOCTOR¿ ICON WITH THE POWER ON RESET (POR) MESSAGE. IT WAS REPORTED THE PATIENT WAS UNABLE TO ADJUST STIMULATION. IT WAS NOTED THE ISSUE STARTED THE MORNING OF THE CALL. IT WAS REPORTED THE PATIENT HAD AN OVERSTIMULATION SENSATION. IT WAS NOTED THE STIMULATOR WAS OFF AND CHARGED FOLLOWING A TRICKLE CHARGE. IT WAS REPORTED THE PATIENT¿S WHOLE BODY WAS ¿JIGGLING¿ BACK AND FORTH. IT WAS NOTED THE MANUFACTURER REPRESENTATIVE USED THE PHYSICIAN PROGRAMMER AND HAD TO RESET THE DATE AND TIME. IT WAS REPORTED THE ¿JIGGLING¿ STOPPED WHEN THE IMPEDANCE CHECK RAN. IT WAS REPORTED THE PATIENT WAS IN OVERDISCHARGE. IT WAS NOTED A PHYSICIAN MODE RECHARGE (PMR) SUCCESSFULLY RESET THE DEVICE. IT WAS REPORTED THE TRICKLE CHARGE WAS THE DAY PRIOR TO THE SHAKING. IT WAS NOTED THE POR WAS SUCCESSFULLY CLEARED. IT WAS REPORTED THE MANUFACTURER REPRESENTATIVE WAS ABLE TO PROGRAM THE DEVICE NORMALLY. IT WAS NOTED THE SHAKING OCCURRED FROM THE SHOULDERS TO THE WAIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379882 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1