BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3093474 · Received May 6, 2013

    Report

    Report Number
    3004209178-2013-07326
    Event Type
    Injury
    Date Received
    May 6, 2013
    Report Date
    April 12, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A "BAD" FALL IN LATE 2011 AND HER DEVICE HAD NOT WORKED SINCE. AFTER THE FALL, THE PATIENT WAS UNABLE TO HAVE HER DEVICE CHECKED BECAUSE SHE WAS WITHOUT INSURANCE. THE PATIENT'S DEVICE WAS EXPLANTED THE DATE OF THIS REPORT. IT WAS NOTED THE PHYSICIAN PROGRAMMER WAS UNABLE TO COMMUNICATE WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THE PATIENT HAD A "LOSS OF USE SECONDARY TO FALL AND OVERDISCHARGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197270 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