BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 3024090 · Received March 27, 2013

    Report

    Report Number
    3007566237-2013-00907
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    October 24, 2012
    Report Date
    March 8, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS STILL IMPLANTED, THE PATIENT WAS ¿GOING BETTER¿ AND THE BACTERIOLOGY WAS NEGATIVE. IT WAS UNCLEAR IF ¿GOING BETTER¿ REFERRED TO ¿DOING BETTER.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INFECTION AND EXPERIENCED SWEATING. IT WAS ALSO REPORTED A CULTURE WAS TAKEN FROM THE DEVICE POCKET. IT WAS NOTED THERE WAS A "SMALL FISTULA" AND THE PHYSICIAN CHECKED THE BACTERIOLOGY ON THE DEVICE POCKET. IT WAS ALSO REPORTED THE DEVICE REMAINED IMPLANTED AND THE PATIENT EXPERIENCED NO INJURY OR ADVERSE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN UNKNOWN TYPE OF INFECTION. ALSO, IT WAS UNKNOWN IF THERE WAS ANY ANTIBIOTIC TREATMENT NECESSARY FOR THE INFECTION OR IF THERE WERE ANY CULTURES TAKEN. SUBSEQUENT INFORMATION REPORTED THAT AN ACTION OF A WOUND DRESSING WAS TAKEN FOR THE ISSUE. THE ABOVE INFORMATION WAS REPORTED PREVIOUSLY IN REGULATORY REPORT NUMBER 3007566237-2015-01188 GOING FORWARD ALL INFORMATION PERTAINING TO THIS EVENT WILL BE REPORTED THROUGH THIS REGULATORY REPORT. ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A FOREIGN CLINICAL STUDY REPORTED THAT THE LOCATION AND TYPE OF INFECTION WAS REJECTION OF THE STITCH, SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125624 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention