BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3193582 · Received June 25, 2013

    Report

    Report Number
    1627487-2013-10215
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND 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

    IT WAS REPORTED A BREAK IN THE PT'S SCS LEAD WAS IDENTIFIED DISTAL TO THE ANCHOR ((B)(6)). SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A LATER DATE TO RESOLVE THE ISSUE. PLEASE NOTE: ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288937 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3822363

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other