BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3406539 · Received October 11, 2013

    Report

    Report Number
    3004209178-2013-18983
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    September 5, 2013
    Report Date
    September 20, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39286-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S STIMULATOR TURNED ON AND OFF ON ITS OWN, AND HAD BEEN DOING SO SINCE IMPLANT 15 DAYS PRIOR. THE PATIENT ALSO FELT SHOCKS WHEN THEY WALKED. THE PATIENT FELT THAT STIMULATION HAD NOT COVERED THE CORRECT SPOT SINCE IMPLANT, AND SEEMED TO BE OVER TO THE LEFT. IT WAS NOTED THAT THE ADAPTIVESTIM FUNCTION HAD NOT BEEN TURNED ON AND THE ORIENTATION HAD NOT BEEN DONE. BASED ON IMPEDANCES, IT WAS SUGGESTED THAT THE 0-7 TAIL OF THE LEAD NOT BE USED. HOWEVER, NONE OF THE IMPEDANCE MEASUREMENTS WERE OUT OF RANGE. THE IMPEDANCES RANGED FROM 400 ¿ 1031 OHMS. RE RUNNING IMPEDANCES AFTER REPROGRAMMING WAS ALSO SUGGESTED. IT WAS FURTHER STATED THAT THE PATIENT LEFT AFTER THE APPOINTMENT ON (B)(6) 2013 AND SAID THE STIMULATION FELT BETTER. THE PATIENT PLANNED TO HAVE AN X-RAY TO MAKE SURE THE LEADS AND STIMULATOR LOOKED GOOD. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523026 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