BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2939462 · Received February 1, 2013

    Report

    Report Number
    3004209178-2013-01228
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Report Date
    January 17, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REPROGRAMMED BY A COMPANY REPRESENTATIVE THE PREVIOUS DAY. THE PATIENT'S STIMULATION WOULD JUMP F ROM 2.10V TO 2.85V, SOMETIMES WHILE SHE WAS MOVING AND SOMETIMES WHILE SHE WAS STANDING STILL. IT WAS REPORTED THAT THAT STIMULATION WAS SUPPOSED TO COVER HER HIPS AND LEGS, BUT IT WAS NOT QUITE COVERING THE HIP. IT WAS POSSIBLE THAT THE 'ADAPTIVE STIMULATION' WAS CAUSING THE STIMULATION CHANGE, BUT IT THAT DOESN'T EXPLAIN WHY STIMULATION WOULD CHANGE WHILE THE PATIENT WAS STANDING STILL. THE ORIENTATION OF THE DEVICE WAS UPRIGHT. NO FURTHER INFORMATION ABOUT THIS EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44583 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