BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3548090 · Received January 2, 2014

    Report

    Report Number
    3004209178-2014-00063
    Event Type
    Injury
    Date Received
    January 2, 2014
    Report Date
    December 15, 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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3587A25, LOT# N230423, IMPLANTED: 2010-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3587A25, LOT# N136907, IMPLANTED: 2010-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37082-60, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SEIZURE ON (B)(6) 2013. IT WAS NOTED THAT THE PATIENT DID NOT HAVE ANY HISTORY OF SEIZURES. IT WAS REPORTED THAT A PATIENT WAS UNABLE TO ADJUST STIMULATION AND COULD NOT TURN THE STIMULATOR ON. IT WAS REPORTED THAT A ¿CALL YOUR DOCTOR¿ ICON APPEARED ON BOTH THE PATIENT PROGRAMMER AND RECHARGER. IT WAS REPORTED THAT A POR WAS SEEN ON THE PROGRAMMER SCREEN. IT WAS REPORTED THAT A MANUFACTURER¿S REPRESENTATIVE HELPED HER CLEAR THE POR AND RESET THE PROGRAMMER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450 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 00035 YR Other