BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4565141 · Received March 3, 2015

    Report

    Report Number
    3004209178-2015-04038
    Event Type
    Injury
    Date Received
    March 3, 2015
    Report Date
    February 9, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37092, LOT# 235870002, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3986A45, LOT# N101278, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3986A45, LOT# N141948, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS VERY SICK IN INTENSIVE CARE AND THEY WERE LOOKING TO DO AN ABDOMINAL MRI. THE PATIENT HAD NOT BEEN USING THE STIMULATOR FOR A WHILE BECAUSE THE DEVICE WAS NOT EFFECTIVE FOR HER. NO KNOWN DATE CONCERNING THIS WAS PROVIDED. MRI GUIDELINES WERE DISCUSSED. FOLLOW-UP DETERMINED THAT THERE WAS NOT A 50% OR GREATER REDUCTION IN SYMPTOMS. THE CAUSE OF THE EVENT HAD BEEN DETERMINED AND IT WAS NOT RELATED TO THE DEVICE. REPROGRAMMING WAS NOT NEEDED. THE PATIENT HAD EXPERIENCED A LOSS OF THERAPEUTIC EFFECT THAT WAS NOTED TO BE GRADUAL. THERE WAS NO LOSS OF STIMULATION. THE PATIENT WAS NOTED TO HAVE RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE SYSTEM WAS NOTED TO HAVE BEEN EXPLANTED ON (B)(6) 2015. THIS EVENT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148706 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