BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 5225712 · Received November 16, 2015

    Report

    Report Number
    3004209178-2015-22867
    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
    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 A POWER-ON-RESET (POR) MESSAGE ON THE CLINICIAN PROGRAMMER WITH AN ERROR CODE OF 0X400. IT WAS NOTED THAT THE PATIENT HAD A CT SCAN ABOUT 3 MONTHS AGO. THE POR WAS SUCCESSFULLY CLEARED USING THE CLINICIAN PROGRAMMER. THERE WERE NO PATIENT SYMPTOMS REPORTED IN THE EVENT. THE INDICATIONS FOR USE FOR THE IMPLANTED DEVICE WERE NOTED AS RSD/CAUSALGIA-COMPLEX REGIONAL PAIN SYNDROME. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758017 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 00046 YR