BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2772369 · Received October 4, 2012

    Report

    Report Number
    3004209178-2012-08880
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 5, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3998 LOT# V704384 SERIAL#, IMPLANTED: 2011 (B)(6), EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYPE RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4) IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708240 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DEVICE WORKED A 'LITTLE' WHEN THE PATIENT FIRST GOT IT, BUT IT AGITATED HIS SKIN. THE PATIENT HAD INFLAMMATION AND HE COULD NOT SIT DUE TO THE PLACEMENT OF THE STIMULATOR. THE DEVICE WAS REMOVED (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED AN IMPLANTABLE NEUROSTIMULATOR (INS) WAS PLANNED TO BE REMOVED IN "A COUPLE OF WEEKS" DUE TO IRRITATION AND BURNING.

    Devices

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