BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2749147 · Received September 18, 2012

    Report

    Report Number
    3004209178-2012-08217
    Event Type
    Injury
    Date Received
    September 18, 2012
    Report Date
    August 20, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 377660 LOT# V013969, IMPLANTED: 2007 (B)(6). PRODUCT TYPE LEAD PRODUCT ID, 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37744 SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WAS GETTING "SUB-PAR STIMULATION" AFTER AN IMPLANTABLE NEUROSTIMULATOR REPLACEMENT (INS). X-RAYS REVEALED THAT THE LEADS WERE TOO HIGH IN THE SPINE AND THE LEADS MIGRATED "NORTH." A LEAD REVISION WAS DONE. THE PHYSICIAN HAD SUCCESS AT T6 DURING A TRIAL. THE LEADS WERE MOVED TO OVER T8 AND T9. THE PATIENT WAS GETTING "GOOD STIMULATION" AND WAS HAPPIER THAN PREVIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 Required Intervention