BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4170553 · Received October 14, 2014

    Report

    Report Number
    3004209178-2014-19654
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    September 21, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 355531, LOT # N310726, IMPLANTED: (B)(6) 2012, PRODUCT TYPE SCREENING DEVICE; PRODUCT ID 8591-38, LOT # D10031, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT YESTERDAY THE PATIENT GOT INTO A POSITION AND WHEN SHE LIFTED HER LEG UP, THE STIMULATION GOT STRONG. THE STIMULATION CONTINUED TO SURGE WHEN THE PATIENT PUT HER LEG DOWN. THE REMOTE WAS NOT WORKING AS THE PATIENT WAS NOT ABLE TO BRING THE STIMULATION DOWN. THE PATIENT WAS ABLE TO TURN THE IMPLANTABLE NEUROSTIMULATOR (INS) OFF AND IT WAS OFF WHEN SHE MET THE MANUFACTURER REPRESENTATIVE (REP) THE DAY OF THIS REPORT. THE PATIENT PROGRAMMER (PP) WAS NOT SHOWING THAT ADAPTIVE STIM WAS ON, SO THE REP USED THE CLINICIAN PROGRAMMER TO VERIFY THAT ALL GROUPS HAD ADAPTIVE STIM. THE PP WAS NOT SHOWING THE UPRIGHT POSITION. THE REP REPROGRAMMED THE PATIENT TO BE COMFORTABLE, AND THE UPRIGHT AND MOBILE WERE WORKING. THE REP DID NOT ¿FIX¿ THE ORIENTATION, BUT DID CHECK IT AND THEN EXITED OUT. THE CORRECT POSITIONS WERE SHOWED AND THE REP WAS ABLE TO INCREASE AND DECREASE THE VOLTAGE. IMPEDANCES WERE ALL AROUND 1,000 OHMS. THE REP THOUGHT MAYBE THE PROGRAMMER WAS THE ISSUE, BUT IT WAS WORKING AS INTENDED THE DAY OF THIS REPORTED. NO FALLS OR TRAUMA REPORTED. THE PATIENT NOTED SHE WAS DEFIBRILLATED A MONTH AGO AND THE DEVICE WAS OFF. THE CAUSE OF THE EVENT WAS UNKNOWN. NO ACTIONS WERE TAKEN. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651837 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