BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2911429 · Received January 11, 2013

    Report

    Report Number
    3004209178-2013-00486
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Report Date
    December 18, 2012
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD RIGHT LEG PAIN, AND WHEN THE PATIENT TURNED THE SIMULATION UP, THE PAIN GOT WORSE. THE REPORTER STATED THAT WHEN THE PATIENT TURNED THE STIMULATION OFF, THREE MINUTES LATER IT WOULD COME BACK ON. IT WAS REPORTED THAT WHEN THE PATIENT LAID OR SAT DOWN THE STIMULATION INCREASED, BUT IT WAS SUPPOSED TO DO THE OPPOSITE. IT WAS NOTED THAT THESE THINGS STARTED ABOUT TWO WEEKS PRIOR TO THE REPORT, WHEN THE PATIENT ALSO STARTED BECOMING MORE ACTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18625 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