BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 6396451 · Received March 10, 2017

    Report

    Report Number
    3004209178-2017-05436
    Event Type
    Malfunction
    Date Received
    March 10, 2017
    Date of Event
    March 5, 2014
    Report Date
    May 24, 2017
    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

    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 UNSATISFACTORY STIMULATION. THE CLINICAL DIAGNOSIS WAS NOT APPLICABLE. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE. INTERVENTIONS INCLUDED REPROGRAMMING. THE PATIENT COMPLAINED OF STIMULATION CHANGES ON (B)(6) 2014. THE PATIENT COMPLAINED STIMULATION GOING UP AND DOWN. THE ETIOLOGY WAS REPORTED AS POSSIBLY RELATED TO THE DEVICE OR THERAPY AND NOT RELATED TO THE IMPLANT PROCEDURE. THE ETIOLOGY WAS DUE TO PROGRAMMING. RELEVANT MEDICAL HISTORY INCLUDED NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE DEVICE DIAGNOSIS WAS NOT APPLICABLE. THE CLINICAL DIAGNOSIS WAS UNSATISFACTORY ANALGESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178617 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR