BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3061180 · Received April 16, 2013

    Report

    Report Number
    3004209178-2013-06339
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT WAS GETTING A POOR CONNECTION/POOR COMMUNICATION ERROR WHILE TRYING TO ADJUST THE STIMULATOR. IT WAS REPORTED THAT THE STIMULATOR HAD JUST BEEN IMPLANTED ON DAY OF REPORT. IT WAS REPORTED THAT THE PATIENT WAS STILL IN THE HOSPITAL. IT WAS REPORTED THAT THE EDUCATION WAS GIVEN TO THE PATIENT ON USING THE PROGRAMMER. IT WAS REPORTED THAT THE DEVICE WAS TURNED OFF BUT THEY DID NOT KNOW HOW IT GOT TURNED OFF. IT WAS REPORTED THAT THE PATIENT WAS ABLE TO SEE THE SETTINGS AND WAS ABLE TO SEE THAT THE IMPLANT WAS ON. IT WAS REPORTED THAT PATIENT WAS ABLE TO "TURN IT BACK ON AND COULD FEEL IT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS TURNING OFF. THE PATIENT WAS IMPLANTED ON THE DAY OF THE REPORT AND WAS STILL IN THE HOSPITAL. THE REPORTER WANTED TO KNOW HOW TO USE THE PATIENT PROGRAMMER TO CHECK THE IMPLANTABLE NEUROSTIMULATOR (INS). THE REPORTER WAS HOWEVER GETTING THE POOR COMMUNICATION SCREEN. THE ANTENNA WAS POSITIONED ON THE INCISION AND SYNCED, BUT THE REPORTER DID NOT SEE THE INS ICON ON THE SCREEN. THE REPORTER TURNED THE INS ON WITH THE PATIENT PROGRAMMER AND THE PATIENT WAS FEELING STIMULATION. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163477 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