BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4258984 · Received November 18, 2014

    Report

    Report Number
    3004209178-2014-21784
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    October 24, 2014
    Report Date
    October 26, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3587A25, LOT# N231018, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: 2(B)(6) 012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    INFORMATION PREVIOUSLY REPORTED IN THIS REGULATORY REPORT NO LONGER PERTAINS TO THIS DEVICE AND WILL NOW BE CAPTURED IN MANUFACTURING REPORT NUMBER 3004209178-2014-21783. ANY ADDITIONAL INFORMATION WILL BE SENT UNDER THIS REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. THE DISPLAY WAS SHOWING ¿CALL YOUR DOCTOR¿ ICON. THE PATIENT REPORTED POWER ON RESET (POR) CONDITION. THE PATIENT SAW THE WARNING POR ON (B)(6) 2014. REFER TO MANUFACTURER REPORT NUMBER 3004209178-2014-21783.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746716 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 00068 YR