BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4110814 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17550
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    Additional Manufacturer Narrative · 1

    NO DEVICE ANALYSIS WAS PERFORMED; THE DEVICE MET RISK BASED CRITERIA.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_SILICONEANCHOR, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37081-40, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3878-45, LOT# 0208368595, PRODUCT TYPE: LEAD. PRODUCT ID: 3878-45, LOT# 0208370946, PRODUCT TYPE: LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INFECTION OF THE WOUND SITE AND THE DEVICE WAS EXPLANTED. SIGNS AND SYMPTOMS INCLUDED FEVER, REDNESS, AND SWELLING. LABORATORY TESTS FOR C-REACTIVE PROTEIN AND WHITE BLOOD CELL COUNT WERE NORMAL. INTERVENTION INCLUDED ADMINISTERING 625 MILLIGRAMS OF AUGMENTIN THREE TIMES A DAY. THE EVENT RESULTED IN IN-PATIENT HOSPITALIZATION FOR THREE DAYS, SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR BODY FUNCTION. THE EVENT WAS NOTED AS NOT RELATED TO THE DEVICE OR THERAPY AND UNLIKELY RELATED TO THE IMPLANT PROCEDURE. THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A FOREIGN CLINICAL STUDY REPORTED THAT THE LABORATORY TESTS SHOWED CRP AND WBC WERE NORMAL ON (B)(6) 2014. THE ETIOLOGY WAS NOTED AS INCISIONAL SITE/DEVICE TRACT IMPLANTABLE NEUROSTIMULATOR (INS) POCKET. THE EVENT WAS POSSIBLY RELATED TO THE DEVICE OR THERAPY AND POSSIBLY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589967 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention