BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 5225998 · Received November 16, 2015

    Report

    Report Number
    3004209178-2015-22872
    Event Type
    Malfunction
    Date Received
    November 16, 2015
    Report Date
    October 26, 2015
    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 MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 3987A, LOT# N242368, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3987A, LOT# N270796, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STIMULATION FROM THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN CUTTING ON/OFF FOR THE LAST 6 MONTHS (SINCE (B)(6) 2015). THE INDICATIONS FOR USE FOR THE IMPLANTED DEVICE WERE NOTED AS RSD/CAUSALGIA-COMPLEX REGIONAL PAIN SYNDROME. THERE WERE NO FURTHER DETAILS, INTERVENTIONS OR AN OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. SEE MANUFACTURER'S REPORT #3004209178-2015-22867 FOR THE PATIENT'S OTHER DEVICE ISSUE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758346 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 00045 YR