BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2941661 · Received February 4, 2013

    Report

    Report Number
    3004209178-2013-01253
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    January 19, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION DEVICE USED FOR WAS OCCIPITAL NEURALGIA. PRODUCT ID 748925, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 7434A, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3986A, LOT # LC2961, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WENT TO THE EMERGENCY ROOM (ER) COMPLAINING OF SHOCKING. THE PATIENT DID NOT HAVE THEIR PROGRAMMER AND HAD NOT USED IT "IN YEARS." IT WAS STATED THAT THE PATIENT'S FAMILY FELT THAT THERE WAS AN "ISSUE" WITH THE DEVICE. THE DOCTOR WANTED A COMPANY REPRESENTATIVE TO COME AND INTERROGATE THE DEVICE. NO FURTHER INFORMATION ABOUT THE EVENT WAS PROVIDED. IF MORE INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46865 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