BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3242686 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12157
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID 37743 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3777-75 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3777-75 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT NEVER HAD THERAPEUTIC EFFECT. IT WAS NOTED, THE PATIENT HAD HEADACHES AND MIGRAINES AND THE IMPLANTABLE NEUROSTIMULATOR (INS) NEVER REALLY HELPED WITH THE MIGRAINES. THE REPORTER STATED THAT IT DIDN'T WORK AND STIMULATION COULD NOT GET UP TO WHERE THE PAIN WAS IN THEIR HEAD. IT WAS NOTED STIMULATION GOT TO THE TOP OF THEIR EAR, BUT NEVER COULD COVER THE PAIN OR MIGRAINES IN THE TEMPLE AREA. IT WAS FURTHER NOTED THE INS AND LEADS WERE REMOVED IN (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343935 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention