BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 5741551 · Received June 22, 2016

    Report

    Report Number
    3004209178-2016-12685
    Event Type
    Malfunction
    Date Received
    June 22, 2016
    Date of Event
    May 26, 2016
    Report Date
    June 22, 2016
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3487A-56, LOT# V660847, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# V137815, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# V083355, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37082-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE DEVICE DIAGNOSIS WAS HIGH IMPEDANCE. THE CLINICAL DIAGNOSIS WAS ADVERSE STIMULATION PARESTHESIA. THE PATIENT NOTED AN INABILITY TO USE HIS IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM CONTINUALLY DUE TO ADVERSE STIMULATION PARESTHESIA. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE. INTERVENTIONS INCLUDED REPROGRAMMING. DEVICE INTERROGATION SHOWED SOME ELECTRODES WERE OUT OF RANGE, OVER 20,000 OHMS. THE ETIOLOGY WAS NOTED AS RELATED TO THE DEVICE OR THERAPY AND NOT RELATED TO THE IMPLANT PROCEDURE. THE ETIOLOGY WAS NOTED AS RELATED TO THE LEADS WHICH WERE CONNECTED TO INS. RELEVANT MEDICAL HISTORY INCLUDED: PERIPHERAL NEUROPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395100 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 68 YR