BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2973172 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-02973
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    February 8, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD; PRODUCT ID, 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT HAD A REVISION ON (B)(6) 2013 AND THE PATIENT WAS DOING "FINE." IT WAS ALSO REPORTED A NEW LEAD WAS IMPLANTED AND AN OLD LEAD WAS REPOSITIONED.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD A LOSS OF COVERAGE FOLLOWING A MOTOR VEHICLE ACCIDENT. SUBSEQUENT TO THE ACCIDENT, STIMULATION WAS NO LONGER IN THE PATIENT'S RIGHT FOOT. REPROGRAMMING WAS ATTEMPTED BUT UNSUCCESSFUL; THE PATIENT WAS RECEIVING MORE BILATERAL STIMULATION THAN BEFORE AND STIMULATION ONLY TO JUST BELOW THE KNEES. IMPEDANCES WERE WITHIN NORMAL LIMITS. AN X-RAY WAS PERFORMED THAT SHOWED THE LEAD TIP AT MID T12 SPANNING THROUGH L2 IN THE MIDLINE. IT WAS NOTED, THERE WAS LEAD MIGRATION. A REVISION WAS PLANNED TO ADD A LEAD TO THE SYSTEM. PATIENT STATUS AT TIME OF REPORT WAS NOTED AS NO INJURY OR ADVERSE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75609 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