BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 6380341 · Received March 6, 2017

    Report

    Report Number
    3004209178-2017-05063
    Event Type
    Malfunction
    Date Received
    March 6, 2017
    Date of Event
    December 30, 2013
    Report Date
    May 10, 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

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE SIGNS AND SYMPTOMS INCLUDED COMPLAINTS OF INCREASED SPASMS IN UPPER BACK WITH STIMULATION DUE TO INCREASED AMPLITUDE, AMPLITUDE WAS DECREASED AND SYMPTOMS WERE RESOLVED. THE AMPLITUDE PRIOR TO REPROGRAMMING WAS 5.5 IN PROGRAM B AND 3.4 IN PROGRAM J. THE AMPLITUDE WAS CHANGED TO 2.9 IN B AND 1.8 IN J.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL OF A CLINICAL STUDY REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR OTHER NON-MALIGNANT PAIN AND OTHER CHRONIC/INTRACTABLE PAIN OF THE TRUNK/LIMBS. A CLINICAL DIAGNOSIS OF UNSATISFACTORY STIMULATION WAS REPORTED (AND A DEVICE DIAGNOSIS WAS NOT APPLICABLE). ON (B)(6) 2013, THE PATIENT COMPLAINED OF "GRABBING" IN THE UPPER BACK WITH STIMULATION; THERE WERE COMPLAINTS OF INCREASED SPASMS IN THE UPPER BACK WITH STIMULATION. THE ENTIRE SYSTEM WAS REPROGRAMMED AND THE EVENT RESOLVED WITHOUT SEQUELAE. THE EVENT WAS RELATED TO THE DEVICE OR THERAPY, SPECIFICALLY DUE TO PROGRAMMING, AND WAS NOT RELATED TO THE IMPLANT PROCEDURE. THE FINAL PROGRAMMING DATE AND TIME FOR THE MOST RECENT INTERROGATION PRIOR TO THE EVENT OCCURRED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164791 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR