BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUNNELLING TOOL

    MDR report key: 2800889 · Received October 18, 2012

    Report

    Report Number
    1627487-2012-00689
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    DURING THE IMPLANT OF AN OCCIPITAL NERVE STIMULATION LEAD IN GERMANY, IT WAS REPORTED THE TUNNELLING TOOL COULD NOT BE EASILY ADVANCED. THE PHYSICIAN EXPERIENCED DIFFICULTY PASSING THE DEVICE THROUGH THE NECK SUBCUTANEOUS REGION. THE PHYSICIAN MANAGED TO GET THE DEVICE THROUGH BUT SUSPECTS THE ISSUE STEMMED FROM A DULL TIP. THE EVENT ALLEGEDLY RESULTED IN SEVERE PAIN FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUNNELLING TOOL SCS LEAD ACCESSORY LGW ST. JUDE MEDICAL - NEUROMODULATION 1120 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention SCS LEAD, MODEL 3183