BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3002550 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03663
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 25, 2013
    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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: 2011-(B)(4), PRODUCT TYPE LEAD PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: 2011-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 37743, LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT "RECENTLY HAD SEIZURES." IT WAS STATED THAT THE PATIENT HAD NOT HAD ANY SEIZURES SINCE THE IMPLANT WAS PUT IN UNTIL "RECENTLY." IT WAS NOTED THAT THE PATIENT WANTED AN ELECTROENCEPHALOGRAM (EEG). A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105346 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 Other