BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3863625 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11265
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3776-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HIGH IMPEDANCES (>10,000 OHMS) WERE SEEN ON ALL ELECTRODE PAIRS EXCEPT #4 ON THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THE PATIENT HAD A BAD FALL 19 MONTHS AGO AND SUFFERED A C2 FRACTURE, HAD A HALO, AND WAS NOW IN A PERMANENT COLLAR. THE PATIENT WAS PROGRAMMED USING ELECTRODES #2 THROUGH 5 AND FELT THE STIMULATION. THE PATIENT HAD THE INS AND THORACIC LEAD FOR HIP AND LEG PAIN. IT WAS REPORTED THAT THE PATIENT WAS CHARGING ABOUT ONCE A WEEK. IT WAS ALSO REPORTED THAT THE PATIENT WAS NOT A GOOD SURGICAL CANDIDATE AT THIS TIME FOR THEIR DEVICE SYSTEM DUE TO THEIR OTHER HEALTH ISSUES. [OMITTED INFORMATION RELATED TO PE (B)(6) REGARDING THE PATIENT¿S RECHARGING ISSUES] (B)(6) 2014 (REP): FOLLOW UP INFORMATION REPORTED THAT THERE WERE NO PLANNED ACTIONS REGARDING THE HIGH IMPEDANCE ISSUES. IT WAS ALSO REPORTED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. [OMITTED INFORMATION RELATED TO PE (B)(6) REGARDING THE PATIENT¿S RECHARGING ISSUES]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338129 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 00078 YR