BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4774319 · Received May 15, 2015

    Report

    Report Number
    3004209178-2015-09180
    Event Type
    Injury
    Date Received
    May 15, 2015
    Report Date
    April 27, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3487A-56, LOT# V250886, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3487A-56, 46), IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD HER IMPLANT REMOVED BECAUSE SHE DIDN¿T NEED IT ANYMORE. THE PATIENT STATED HER BRAIN INJURY HEALED ON ITS OWN. THE THERAPY WORKED WELL. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PAINFUL BECAUSE SHE WAS SO SKINNY. THE PATIENT HAD TROUBLE SLEEPING WITH IT, BUT THE THERAPY WORKED FOR HER. THE PATIENT WAS REDIRECTED TO THE REPAIR DEPARTMENT TO DONATE HER PROGRAMMER AND RECHARGER. THERE WERE NO DEVICE ISSUES REPORTED. THERE WAS NO OUTCOME REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318451 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 00039 YR Required Intervention