BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 5481308 · Received March 4, 2016

    Report

    Report Number
    3004209178-2016-03949
    Event Type
    Injury
    Date Received
    March 4, 2016
    Report Date
    February 8, 2016
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 377760, LOT# V003347, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 377760, LOT# V003347, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR OTHER CHRONIC/INTRACT PAIN (TRUNK/LIMBS). IT WAS REPORTED THAT STIMULATION WAS NOT CURRENTLY ON BECAUSE IT DID NOT WORK. THIS WAS STATED TO BE A SUDDEN CHANGE IN 2015. THE PATIENT STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) STOPPED WORKING. IT FELT LIKE THE INS "HAD A SHORT LIKE IT WAS SHORTING OUT." THE PATIENT STATED THAT THEY WOULD MOVE THEIR BODY ONE WAY AND WOULD NOT FEEL STIMULATION AND THEN MOVE THEIR BODY ANOTHER WAY AND WOULD FEEL STIMULATION. THE PATIENT STATED THAT THEIR HEALTH CARE PROFESSIONAL (HCP) TOLD THEM THAT THERE WAS SOMETHING WRONG WITH THE WIRES. IT WAS LATER REPORTED THAT THE INS DID NOT WORK AT ALL ANYMORE AND THAT THEIR MANAGING PAIN HCP KNEW THAT IT WAS NOT WORKING. THE INS WAS REPORTED TO ORIGINALLY HAVE BEEN FOR PAIN IN THEIR RIGHT LEG. NO STEPS WERE REPORTED TO HAVE BEEN DONE OR WILL BE DONE IN THE FUTURE TO RESOLVE THIS ISSUE AS IT WAS STATED THAT THE PATIENT NO LONGER NEEDED THE INS BECAUSE THEIR HCP GAVE THEM INJECTIONS FOR PAIN NOW AND THE INJECTIONS GOT RID OF 100% OF THEIR PAIN. IT WAS STATED THAT THE INS HAD NOT HELPED NEARLY AS MUCH. THE PATIENT REPORTED THAT THEY HAD DECIDED WITH THEIR HCP THAT THE DEVICE WOULD BE LEFT IN AS IS UNLESS SOMETHING ELSE CAME UP AND IT WAS NEEDED OR IF IT CAUSED A PROBLEM. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138275 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention