BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 5521168 · Received March 23, 2016

    Report

    Report Number
    3004209178-2016-05229
    Event Type
    Injury
    Date Received
    March 23, 2016
    Report Date
    April 21, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE. THE POSSIBLE WOUND INFECTION WAS AT MIDLINE LUMBAR INCISION.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED A POSSIBLE WOUND INFECTION. THERE WERE NO LABS DRAWN OR CULTURES TAKEN. WHEN THEY LOOKED CLOSER IT DID NOT LOOK INFECTED BUT THEY CLEANED IT WITH ANTIBIOTIC SOLUTION ANYWAY. THE OUTCOME WAS ONGOING. INTERVENTIONS INCLUDED WOUND FLUSHING WITH ANTIBIOTIC SOLUTION. THE PATIENT RECEIVED IV ANTIBIOTICS AND ORAL ANTIBIOTICS. NO DIAGNOSTIC METHODS WERE PERFORMED. THE ETIOLOGY WAS NOTED AS NOT RELATED TO THE DEVICE OR THERAPY AND POSSIBLY RELATED TO THE IMPLANT. SIGNS AND SYMPTOMS INCLUDED AN OPEN WOUND AT PROXIMAL END OF MIDLINE INCISION. THE SEVERITY WAS NOTED AS MILD. RELEVANT MEDICAL HISTORY INCLUDED: NON-MALIGNANT PAIN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175618 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