BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4919255 · Received July 16, 2015

    Report

    Report Number
    3004209178-2015-13535
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Report Date
    June 25, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    9840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_ENS_STIMULATOR, PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V143279, IMPLANTED: (B)(6)2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37082-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3888-33, LOT# V248575, IMPLANTED: (B)(6)2009, PRODUCT TYPE: LEAD. PRODUCT ID: 977D160, SERIAL# (B)(4), PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID: NEU_ENS_STIMULATOR, PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SURGING SENSATION. THE PATIENT WAS UNDERGOING A TRIAL TO TAKE CARE OF A NEW PAIN PATTERN. THEY FELT SURGING WHEN BOTH THE TRIAL LEADS AND THE PERMANENT EPIDURAL LEAD WERE ON. THE MANUFACTURER REPRESENTATIVE (REP) NOTED THAT THEY PROGRAMMED THEM TO THE SAME RATE BUT THAT DID NOT RESOLVE THE ISSUE. IT WAS LATER REPORTED THAT THE PATIENT RAN THE TRAIL SYSTEM INDEPENDENTLY OF THE PERMANENT SYSTEM. IF ADDITIONAL INFORMATION IS RECEIVED, THE EVENT WILL BE UPDATED AND A FOLLOW-UP REPORT WILL BE SENT IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464118 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 00072 YR