BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3232192 · Received July 17, 2013

    Report

    Report Number
    3004209178-2013-11910
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE STIMULATION WAS TURNED ON, EVERY NOW AND THEN, IF THE PATIENT STRETCHED THEIR ARM OR LEANED FORWARD OR TO THE SIDE, THE IMPLANTABLE NEUROSTIMULATOR DECREASED IN INTENSITY BUT WOULD START BACK UP IN 5 TO 10 MINUTES. IT WAS NOTED THAT WHEN THE PATIENT WAS WALKING, HE WOULD LOSE IT SOMETIMES BUT FOUND OUT THAT HE NEEDED TO SET THE WALKING SETTING WHEN HE WAS ACTUALLY WALKING. IT WAS NOTED THAT THIS BEGAN IN THE LAST COUPLE WEEKS. IT WAS NOTED THAT THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331090 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