BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUNNELING TOOL, 12"

    MDR report key: 2192929 · Received July 19, 2011

    Report

    Report Number
    1627487-2011-00997
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K092371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: INSPECTION OF THE TUNNELING TOOL REVEALED THAT OUTER SLEEVE WAS COMPRESSED IN SEVERAL LOCATIONS ALONG THE LENGTH OF THE TOOL. THE TUNNELING TOOL HAD A SLIGHT CURVE USED TO CONFORM TO THE CONTOUR OF THE PT'S BODY. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DURING A PERMANENT TRIAL PROCEDURE IN (B)(6) TO EXTERNALIZE THE PT'S EXTENSIONS, IT WAS REPORTED THAT THE SLEEVE OF THE TUNNELING TOOL COLLAPSED. TO PREVENT RECURRENCE OF THE ISSUE, THE IMPLANTING PHYSICIAN USED A SCALPEL TO MAKE THE EXIT POINT FOR THE EXTENSIONS LARGER. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUNNELING TOOL, 12" SPINAL CORD STIMULATION LEAD ACCESSORY GZB ST. JUDE MEDICAL - NEUROMODULATION 1112 3345990

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention