BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 6761061 · Received August 2, 2017

    Report

    Report Number
    3004209178-2017-16090
    Event Type
    Malfunction
    Date Received
    August 2, 2017
    Date of Event
    July 29, 2017
    Report Date
    August 2, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    UDI-DI
    00613994610430
    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

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 37746,SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL PAIN. IT WAS REPORTED THAT THERE WERE POSITIONAL STIMULATION CHANGES STARTED ON (B)(6) 2017. IT WAS REPORTED THAT THEIR LEG WANTED TO DO A TAP-DANCE ALL BY ITSELF. THERE WERE NO RELATED FALLS OR TRAUMAS. THIS WAS NOTICED 3 DAYS AGO AND HAD GOTTEN WORSE AND WORSE. WHEN THE PATIENT LAID DOWN IT REALLY WENT HOG WILD SO THE PATIENT WENT TO ADJUST IT LAST NIGHT BUT THE PATIENT PROGRAMMER WOULD NOT TURN ON. THE PATIENT PROGRAMMER SCREEN WOULD NOT POWER ON STARTING LAST NIGHT (B)(6) 2017. THE PATIENT WAS USING HEAVY DUTY BATTERIES. IT WAS RECOMMENDED FOR THE PATIENT TO TRY REGULAR ALKALINE BATTERIES. THE PATIENT STATED THAT THEY WOULD GO TO GET SOME SOON AND WOULD CALL BACK IF THE ISSUE DID NOT RESOLVE WITH USING REGULAR ALKALINE BATTERIES. THE PATIENT COULD NOT TROUBLESHOOT THEIR POSITION STIMULATION ISSUES ON THE CALL DUE TO THEIR PATIENT PROGRAMMER NOT TURNING ON. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541640 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714 00613994610430

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR