BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3011587 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03944
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 28, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT # V592257, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED CONTINUOUS PAIN GOING DOWN HIS LEG THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) "SHOULD HAVE ADDRESSED." IT WAS STATED THAT THE PATIENT'S HEALTHCARE PROVIDER (HCP) SUSPECTED THE INS WAS "NOT WORKING PROPERLY." IT WAS ALSO STATED THAT THE INS HAD FLIPPED AND THE PATIENT "WAS CATCHING THE CORNER ON THINGS." IT WAS STATED THAT HAD HAPPENED ABOUT A YEAR PRIOR TO REPORT AND WAS "GETTING WORSE." THE PATIENT WAS REDIRECTED TO THEIR HCP AND IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113601 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