BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4252888 · Received November 11, 2014

    Report

    Report Number
    1627487-2014-20415
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 21, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AN IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT# 1627487-2014-20414. IT WAS REPORTED THE PATIENT EXPERIENCED LOSS OF THERAPY. REPROGRAMMING WAS UNSUCCESSFUL. X-RAYS DETERMINED FRACTURE ON ONE OF THE LEADS. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE. THE PATIENT RECEIVED TWO SCS LEADS. IT IS UNKNOWN WHICH LEAD IS RELATED TO THE ISSUE. THEREFORE, BOTH ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725918 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4409987

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (3)| SCS IPG: MODEL 3788| IMPLANT DATE: