BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 2962057 · Received February 14, 2013

    Report

    Report Number
    3007566237-2013-00486
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THEY HAD NOT BEEN FEELING WELL OVER THE PAST FEW YEARS. FOLLOWING THE EXPLANT OF THEIR PUMP THE CATHETER WAS LEFT IN THEIR BODY. LESS THAN ONE WEEK AFTER THE EXPLANT THEY EXPERIENCED SPINAL HEADACHES DUE TO SPINAL FLUID LEAKING BACK IN TO THE POUCH. THE SPINAL FLUID WAS LEAKING BACK DOWN THE CATHETER. THE HCP REMOVED THE TIP OF THE CATHETER AND DID A BLOOD PATCH. THE PATIENT CONTINUED TO HAVE PAIN ON THEIR RIGHT SIDE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE BLOOD PATCH HAD BEEN DONE IN (B)(6) 2007, WHICH HELPED THE SPINAL HEADACHE. IT WAS NOTED THE PATIENT'S PUMP HAD ALREADY BEEN REMOVED PRIOR TO THE TIME OF THE EVENT (REFER TO MANUFACTURER REPORT #6000030-2013-00023) AND HAD BEEN PREVIOUSLY USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65869 INDURA PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8709 L63770

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention