BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3173739 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10491
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 28, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3550-39, LOT# N310571, IMPLANTED: (B)(6) 2012; PRODUCT TYPE ACCESSORY, PRODUCT ID 3 9286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012; PRODUCT TYPE LEAD, PRODUCT ID 37092, LOT# 285240002; PRODUCT TYPE ACCESSORY, PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A HEAD MRI IN (B)(6) 2013 AND HE HAD SYNCHRONIZATION PROBLEMS WITH HIS PATIENT PROGRAMMER AFTER THE MRI. IT WAS NOTED THAT IT HAD SINCE RESOLVED ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273184 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 00033 YR