BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3492821 · Received November 27, 2013

    Report

    Report Number
    3004209178-2013-21625
    Event Type
    Malfunction
    Date Received
    November 27, 2013
    Report Date
    November 12, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3587A, LOT# LB8145, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. PRODUCT ID: 74001, LOT# N210464, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ADAPTER. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 355531, LOT# N293566, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ORIGINALLY AFTER IMPLANT THE DEVICE WAS ¿SUPERB¿ AND IT HELPED. IT WAS NOTED THAT THE PATIENT HAD GOTTEN THE 16 PADDLE AND IT HAD GREAT COVERAGE IN HER BACK AND LEGS. IT WAS NOTED THAT THE PATIENT ¿BENT OVER AND THE STIMULATOR SHUT OFF.¿ IT WAS NOTED THAT THE PATIENT WENT TO THE DOCTOR AND THEY WERE NOT ABLE TO GET THE GOOD COVERAGE BACK. IT WAS NOTED THAT THE PATIENT HAD A NEW DOCTOR AND HE WANTED TO TRY REPROGRAMMING TO COME UP WITH SOMETHING BETTER. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618713 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