BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 6999654 · Received November 3, 2017

    Report

    Report Number
    3004209178-2017-23112
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    November 2, 2017
    Report Date
    November 15, 2017
    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE (REP). IT WAS REPORTED THAT THE CAUSE OF THE HIGH IMPEDANCE WAS NOT DETERMINED. THE HEALTH CARE PROFESSIONAL (HCP) IS CONFIDENT THAT THE PATIENT CAN USE 4 WORKING CONTACTS TO ACHIEVE DESIRED THERAPY AS AN ACTION/ INTERVENTION TOWARDS THE HIGH IMPEDANCE ISSUE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED IN THIS EVENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR RSD/CAUSALGIA-COMPLEX REGIONAL PAIN SYN. INFORMATION WAS REPORTED THAT AN ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE WAS SEEN. THERE IS NO ALLEGATION/DISSATISFACTION WITH LONGEVITY. ERI NOTIFICATION SEEMED CORRECT RELATIVE TO IMPLANT DATE. IT WAS REPORTED THERAPY IS GOOD. THE CALLER REPORTED ELEVATED IMPEDANCES. 0-7 ELECTRODE ARE > 20,000 OHMS (ALL COMBINATIONS). 8-15 HAVE SOME VIABLE ELECTRODES, 8 & 9 = 411, 8 & 10 478, 8 & 11 660, 8 & 12 = 14559, 8 & 13 18112, 8 & 14 > 20,00 AND 8 & 15 = 8101. IT WAS REVIEWED POSSIBLE CONNECTION OR LEAD FRACTURE/DAMAGE. REVIEWED SURGICAL OPTIONS. PATIENT WILL BE GETTING INS REPLACED (B)(6) 2017 DUE TO ERI/EOS. PATIENT IS GETTING GOOD THERAPY BENEFIT AND REASON FOR VISIT TODAY WAS TOO CHECK SYSTEM BEFORE REPLACEMENT SURGERY. NO FURTHER COMPLICATIONS WERE REPORTED. NO PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778012 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 43 YR