BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2891763 · Received December 31, 2012

    Report

    Report Number
    3004209178-2012-12414
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    December 7, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID 7434-E, SERIAL# (B)(4), IMPLANTED: (B)(6) 1996, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3888-28, LOT# L40605, IMPLANTED: (B)(6) 1996, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S BROKEN LEAD WAS REPLACED AND HIS THERAPY HAD RESUMED.

    Description of Event or Problem · 1

    IT WAS REPORTED PRONGS OF THE EXTENSION WERE BROKEN. IT WAS ALSO REPORTED WHEN STIMULATION WAS TURNED ON THERE WAS NO STIMULATION SE NSATION. IMPEDANCES WERE ALL WITHIN NORMAL RANGE BUT PATIENT WAS NOT FEELING ANY STIMULATION WITH TEST STIMULATOR ON THE TABLE. THEY PLACED ORIGINAL QUAD LEAD IN 1X8 SLOT THEN TRIED USING 1X4 SLOT. WHEN THEY USED THE 1X4 THEY GOT IMPEDANCES GREATER THAN 40,000 OHMS. IT WAS NOTED THE PATIENT HAD NOT USED STIMULATION FOR SEVERAL YEARS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 00050 YR