BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3203125 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11219
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 13, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3777-75, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3777-75, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010-04-02, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS "DOING WELL" FOLLOWING THE REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR A LEAD REVISION BECAUSE THE LEADS HAD MOVED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEFT LEAD PULLED DOWN. THE PATIENT WAS GETTING STIMULATION DOWN HIS ARM WHICH INDICATED NERVE ROOT STIMULATION. THE REVISION WAS SCHEDULED FOR (B)(6) 2013. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302279 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