BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4403056 · Received January 9, 2015

    Report

    Report Number
    3004209178-2015-00421
    Event Type
    Malfunction
    Date Received
    January 9, 2015
    Report Date
    December 16, 2014
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377760, LOT# V012405, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 377760, LOT# V012405, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37742, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD BEEN HAVING PROBLEMS WITH THEIR IMPLANTABLE NEUROSTIMULATOR (INS) SINCE IMPLANT. WITHIN THE LAST 4-5 MONTHS THE PATIENT HAD BEEN HAVING MORE BACK AND LEG PAIN. EVERY TIME THE PATIENT WENT TO USE THE PATIENT PROGRAMMER THEIR LEGS AND ARMS WOULD GO STRAIGHT UP IN THE AIR AND THEY WOULD HURT EVENT MORE. THE PATIENT STATED THEY DID NOT FEEL RIGHT. THERAPY HAD NOT BEEN USED SINCE 2007, BECAUSE THE PATIENT HAD PROBLEMS WALKING, THEIR FEET WOULD TINGLE, AND THEY COULD NOT FEEL THEIR FEET WHEN WALKING. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23391 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR