BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER, UNKNOWN

    MDR report key: 3891087 · Received June 24, 2014

    Report

    Report Number
    3007566237-2014-01751
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER FOUND CATHETER BODY DAMAGE, THE DAMAGE OCCURRED TO THE CATHETER BODY AND/OR GUIDEWIRE DURING THE IMPLANT PROCEDURE. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE BELIEVED A RECENT SURGERY HAD BEEN PERFORMED TO REMOVE THE LOST TIP OF THE CATHETER. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRIAL IMPLANT PROCEDURE, THE CATHETER COILED UP IN THE INTRATHECAL SPACE. WHILE ATTEMPTING TO REMOVE THE CATHETER AND NEEDLE TOGETHER, THE NEEDLE SLICED THE TIP OF THE CATHETER AND IT REMAINED IN THE INTRATHECAL SPACE. THERE WERE REPORTEDLY NO KNOWN SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE CATHETER WOULD BE USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367734 CATHETER, UNKNOWN CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_CATH C66916

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Other| R