BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4669203 · Received April 8, 2015

    Report

    Report Number
    3004209178-2015-06178
    Event Type
    Malfunction
    Date Received
    April 8, 2015
    Date of Event
    September 18, 2014
    Report Date
    March 18, 2015
    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 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3987A, LOT # N189094, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3987A, LOT # N242432, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37092, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED NO STIMULATION SENSATION. THE PATIENT HAD A TRUE PERIPHERAL NERVE STIMULATION (PNS) SYSTEM FOR RIGHT SCIATIC NERVE AND LOWER EXTREMITY COMPLEX REGIONAL PAIN SYNDROME. THE PATIENT COMPLAINED THAT THE DEVICE WAS SHUTTING OFF ON THE PATIENT. IT OCCURRED RANDOMLY AND HAD HAPPENED 4 TIMES OVER THE COURSE OF THE PAST 6 MONTHS. SINCE THE PATIENT HAD A TRUE PNS SYSTEM THE EVENTS CAUSED THE PATIENT TO LOSE BALANCE AND FALL. THE REPORTER STATED THAT WHEN THE IMPLANT TURNED OFF IT COMES BACK ON BY ITSELF. THE PATIENT DID NOT USE THE PROGRAMMER TO CONFIRM THAT THE IMPLANT WAS OFF. IT OCCURRED WHILE WALKING AND NOT WITH A SPECIFIC CHANGE IN POSITION. THE SYSTEM WAS INTERROGATED AND THERE WAS NO IMPEDANCE ISSUE AND PROGRAMMING GOT THE COVERAGE THE PATIENT NEEDED. BOTH LEADS WERE ACTIVE AND THE PATIENT WAS REPROGRAMMED ON THE DAY OF REPORT TO P1: 1.4 VOLTS, 1+ A AND 3 ¿ ON ONE LEAD AND P2: UNKNOWN VOLTAGE, 5 - 7 + ON THE OTHER LEAD. THE PATIENT WAS INCREASED TO 100 HZ FROM 40 HZ AND THE PULSE WIDTH WAS DECREASED TO 150'S FROM 180'S. THE PATIENT WAS GOING TO TRY THE NEW GROUP WHICH HAD DIFFERENT ELECTRODES THAN THE PREVIOUS GROUP DID. THE REPORTER WAS UNABLE TO ELICIT, WITH MANUAL PALPATING OVER THE SITE, ANY LOSS OF STIMULATION. THE PATIENT WAS INSTRUCTED TO FOLLOW UP IMMEDIATELY IF THE PROBLEM RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231160 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 00043 YR