BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3719226 · Received April 1, 2014

    Report

    Report Number
    3004209178-2014-05440
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Report Date
    March 13, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37092, LOT# 272450001, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD FALLEN AND BROKE HER ANKLE IN NOVEMBER, SPENT THREE MONTHS IN THERAPY, AND WAS HAVING BACK PAIN. IT WAS NOTED THAT THE PATIENT THOUGHT IT WOULD BE A GOOD IDEA TO MEET WITH THE MANUFACTURER'S REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT RETURNED HOME FROM THERAPY AT THE END OF FEBRUARY AND HAD BEEN WORKING WITH A PHYSICAL THERAPIST AT HOME. IT WAS NOTED THAT THE PATIENT'S ANKLE WAS BETTER AT THE TIME OF REPORT BUT THE BACK PAIN SEEMED TO BE AN ISSUE. IT WAS NOTED THAT THE BACK PAIN HAD BEEN HURTING "ON AND OFF FOR SOME TIME." THE PATIENT REPORTED THAT WHEN SHE MOVED A CERTAIN WAY, HER THERAPIST SAID "HMM SOUNDS LIKE A SCIATIC NERVE." THE PATIENT REPORTED A LOSS OF THERAPEUTIC EFFECT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194607 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 00075 YR