BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3222815 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11665
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37746, SERIAL# (B)(4): PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID 37754, SERIAL# (B)(4): PRODUCT TYPE RECHARGER, PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012: PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S PROGRAMMER ¿POOPED OUT.¿ IT WAS NOTED THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. IT WAS FURTHER NOTED A ¿CALL YOUR DOCTOR¿ ICON AND OUT OF REGULATION (OOR) MESSAGE WERE DISPLAYED. THE REPORTER STATED THE OOR MESSAGE WAS DISPLAYED AFTER THE PATIENT PLACED THE ANTENNA OVER THE IMPLANTABLE NEUROSTIMULATOR AND PRESSED THE SYNC BUTTON. IT WAS NOTED THE PATIENT HAD SEEN THE OOR MESSAGE ONCE BEFORE. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324261 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 00040 YR