BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2597517 · Received June 4, 2012

    Report

    Report Number
    3004209178-2012-03996
    Event Type
    Injury
    Date Received
    June 4, 2012
    Report Date
    May 7, 2012
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-45, LOT # V191307, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3487A-45, LOT # V191307, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE IMPLANTABLE NEUROSTIMULATOR WAS ON OR OFF, THERE WAS A PINCHING SENSATION, DIZZY SPELLS, INCREASED PAIN, AND DIFFICULTY WALKING AND BENDING OVER. THESE SYMPTOMS WERE ONGOING. THERE WAS NO KNOWN ACCIDENT OR INCIDENT. THERE WAS A FALL A YEAR AGO, WHERE THE PATIENT HAD HIT HIS HEAD, WHICH KNOCKED HIM UNCONSCIOUS. THE SYMPTOMS WERE AT THE LEAD LOCATION. THE PATIENT'S STATUS WAS SERIOUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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