BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2990941 · Received March 6, 2013

    Report

    Report Number
    3004209178-2013-03366
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    February 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 PRODUCT ID, 3708220 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3487A-56 LOT# V396202, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3487A-56 LOT# V396202, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DAY PRIOR TO THE REPORT, THE PATIENT STARTED CHARGING HIS DEVICE FOR FIVE MINUTES AND THEN HIS BODY WENT INTO A CONVULSION FOR TWO TO THREE MINUTES. THE PATIENT STOOD UP AND FELT LIKE HE WAS "HIT WITH A BAG OF ICE" AND FELT VERY COLD. THE PATIENT THEN WENT TO BED AND TRIED TO WARM UP. THE PATIENT FELL ASLEEP AND WOKE UP EARLY MORNING AND ALL OF HIS LIGHTS AND COMPUTERS WERE ON. THIS HAD NEVER HAPPENED BEFORE TO THE PATIENT AND HE HAD NOT TOLD HIS HEALTH CARE PROVIDER (HCP) ABOUT THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95378 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 Other