BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4163517 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19448
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    September 22, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3888-33, LOT # J0417694V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 74002, LOT # N257780, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ADAPTER; PRODUCT ID 3550-09, LOT # LB6791, IMPLANTED: (B)(6) 2004, PRODUCT TYPE ACCESSORY; PRODUCT ID 748951, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEIR STIMULATION FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) SUDDENLY ¿STOPPED WORKING RIGHT¿ AND THAT IT WAS NOT WORKING THE WAY IT USED TOO. THE PATIENT STATED THAT ¿NOTHING HAPPENED¿ AND FELT THE STIMULATION MORE IN THEIR LEGS THAN IN THEIR UPPER BODY WHERE IF SHOULD BE. IMPEDANCE TESTING SHOWED THAT ONE ELECTRODE WAS OUT OF RANGE (HIGH). REPROGRAMMING WAS ALSO PERFORMED AFTER WHICH THE PATIENT NOTED AN IMPROVEMENT IN THE PARASTHESIA LOCATION BUT HAD SINCE REPORTED THAT IT WAS STILL NOT HELPING THEM. PATIENT SYMPTOMS OF LESS THAN 50% THERAPY RELIEF WAS REPORTED AS A RESULT OF THE EVENT ISSUE. THE PATIENT WAS OFFERED TIPS FOR ADJUSTMENT OF THEIR STIMULATION SUCH AS AMPLITUDE AND RATE ADJUSTMENT OPTIONS AND THEY STATED THEY WERE GOING TO SEE IF THAT HELPED THEM. THE PATIENT STATUS AT THE TIME OF REPORT WAS NOTED AS ¿ALIVE ¿ NO INJURY.¿ THERE WERE NO FURTHER DETAILS, INTERVENTIONS OR OUTCOME 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
    639809 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