BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDE WIRE FOR PERCUTANEOUS LEAD

    MDR report key: 2191231 · Received July 29, 2011

    Report

    Report Number
    1627487-2011-07007
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE GUIDE WIRE WAS OBSERVED TO BE OVERSTRESSED AND DEFORMED. APPROX 8CM FROM THE LEADING END. ACCORDING TO THE REPORTED EVENT, THE DAMAGE OCCURRED DURING THE ATTEMPT TO IMPLANT THE LEADS. 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

    IT WAS REPORTED ON (B)(6) 2011 THAT DURING A PERMANENT SCHEDULED SCS SYSTEM PROCEDURE ON (B)(6) 2010 FOR 2 LEADS, THE DOCTOR EXPERIENCED DIFFICULTIES. THE FIRST LEAD WAS PLACED, BUT WHEN A LATERAL FLUORO WAS TAKEN, IT WAS FOUND TO BE ANTERIOR. THE DR ATTEMPTED TO MOVE THE LEAD POSTERIOR, BUT WAS UNSUCCESSFUL. HE REMOVED THE LEAD AND NEEDLE. HE ATTEMPTED TO INSERT A COUDE NEEDLE. AFTER PLACING THE COUDE NEEDLE, HE USED A GUIDE WIRE TO CHECK ACCESS, BUT WAS UNSUCCESSFUL. HE PULLED THE NEEDLE OUT, AND ATTEMPTED TO PULL THE GUIDEWIRE, BUT THE GUIDEWIRE WAS STUCK, AND HE COULDN'T REMOVE IT. THE GUIDEWIRE WAS NOT IN THE EPIDURAL SPACE. THE DR CALLED FOR A NEURO SURGEON, WHO PERFORMED A SMALL INCISION AND EASILY REMOVED THE GUIDEWIRE. THE CASE WAS SUBSEQUENTLY ABORTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE WIRE FOR PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD ACCESSORY LGW ST. JUDE MEDICAL - NEUROMODULATION 1102 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention