BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 5990725 · Received September 30, 2016

    Report

    Report Number
    3004209178-2016-20138
    Event Type
    Injury
    Date Received
    September 30, 2016
    Date of Event
    June 1, 2016
    Report Date
    September 30, 2016
    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

    Description of Event or Problem · 1

    A HEALTH CARE PROVIDER (HCP) FOR A CLINICAL STUDY REPORTED VIA A MANUFACTURING REPRESENTATIVE THAT THE PATIENT HAD AN ABDOMINAL WOUND INFECTION. THE PATIENT SHOWED SIGNS OF SUPERFICIAL INFECTION AT THEIR POST OPERATION WOUND REVIEW ON (B)(6) 2016. BLOOD WAS TAKEN TO BE TESTED AND THE PATIENT'S CRP WAS SLIGHTLY RAISED AT 8. THE PATIENT'S WHITE BLOOD CELL COUNT WAS NORMAL. INTERVENTIONS INCLUDED ADMINISTERING 500 MG FLUCLOXACILLIN QDS ON (B)(6) 2016. THE PATIENT STILL SHOWED SIGNS OF INFECTION ON (B)(6) 2016 SO ANTIBIOTICS WERE CONTINUED AND STERISTRIPS WERE APPLIED OVER THE WOUND SITE TO AID HEALING. THE WOUND LOOKED BETTER ON (B)(6) 2016, BUT A FURTHER TWO WEEKS OF FLUCLOXACILLIN QDS WAS PRESCRIBED. REVIEW OF THE WOUND ON (B)(6) 2016 FOUND THE WOUND WAS HEALING WELL SO ANTIBIOTICS WERE STOPPED. ON (B)(6) 2016, THERE WERE NO SIGNS OF INFECTION AND THE WOUND HAD HEALED. THE EVENT RESULTED IN AN UNSCHEDULED CLINIC OR OFFICE VISIT. THE EVENT WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2016. THE ETIOLOGY WAS NOT RELATED TO THE DEVICE OR THERAPY AND RELATED TO THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641248 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention