BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 6293357 · Received February 1, 2017

    Report

    Report Number
    3004209178-2017-02280
    Event Type
    Injury
    Date Received
    February 1, 2017
    Date of Event
    August 1, 2008
    Report Date
    February 1, 2017
    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT. IT WAS REPORTED THAT THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS GETTING TOWARDS END OF LIFE. THE PATIENT STATED THAT THEY DIDN¿T KNOW WHAT TO DO BECAUSE THEY WERE NOT VISITING THE SAME HEALTHCARE PROVIDER (HCP) AND DIDN¿T WANT TO WAIT UNTIL THE INS DIES. THE PATIENT REPORTED THAT TWO MONTHS AFTER THEY WERE IMPLANTED, THE INS HAD TO BE ¿REDONE¿ OR REPOSITIONED. IT WAS NOTED THAT THE PATIENT¿S TRIAL WORKED GREAT AND STIMULATION WAS ABLE TO REACH THEIR FEET. THE PATIENT REPORTED THAT WITH THEIR PERMANENT IMPLANT, STIMULATION DIDN¿T ALWAYS GET TO THEIR FEET AND WOULD CHANGE EVERY TIME THEY MOVED. THE PATIENT STATED THAT THE PRODUCT WAS GREAT AND HAD HELPED THEM A LOT. THE PATIENT WAS TO FOLLOW UP WITH THEIR HCP REGARDING DEVICE OPTIONS AND LONGEVITY. IT WAS REVIEWED THAT BATTERY LONGEVITY DEPENDS ON USAGE AND SETTINGS. IT WAS ALSO RECOMMENDED THAT THE PATIENT LOOK AT THEIR PROGRAMMER SCREEN FOR CODES OR INFORMATION AND CALL IF THEY HAD ANY QUESTIONS. INDICATION FOR USE IS PERIPHERAL NEUROPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77933 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention