BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2835516 · Received November 16, 2012

    Report

    Report Number
    3004209178-2012-10375
    Event Type
    Injury
    Date Received
    November 16, 2012
    Report Date
    October 19, 2012
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3777-75 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 355531 LOT# N331026, IMPLANTED: 2012 (B)(6), EXPLANTED: PRODUCT TYPE SCREENING DEVICE PRODUCT ID, 355028 LOT# N329983N01, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-43 LOT# N197618, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-39 LOT# N335359, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-29 LOT# N250164, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEAD MIGRATED AND PARASTHESIA WAS IN THE WRONG PLACE. THE AREA WITH CHRONIC PAIN WAS NOT BEING COVERED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 REPORTED THAT LEAD REVISION WAS COMPLETED ON (B)(6) 2012. THE EXISTING LEAD WAS REPOSITIONED TO THE CORRECT LEVEL AND THE PATIENT WAS GETTING STIMULATION IN THE AREAS HE NEEDED. THE PATIENT WAS "VERY PLEASED" AND NOTHING WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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