BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1420837 · Received July 23, 2009

    Report

    Report Number
    2182207-2009-05097
    Event Type
    Injury
    Date Received
    July 23, 2009
    Date of Event
    June 29, 2009
    Report Date
    June 29, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER.

    Description of Event or Problem · 1

    THE PT HAD BEEN EXPERIENCING INCREASED PAN. A DYE STUDY WAS ATTEMPTED AND ABORTED BECAUSE FLUID WAS NOT ABLE TO BE ASPIRATED. IT WAS DETERMINED THAT THE CATHETER HAD A KINK OR OCCLUSION AT AN UNSPECIFIED LOCATION. DURING SURGERY, THE CATHETER WAS DISCONNECTED BUT AFTER CUTTING AND MANIPULATING THE CATHETER, FREE FLOW SPINAL FLUID HAD STARTED. DUE TO NOT WANTING THE PT TO HAVE FLUID ACCUMULATION OR A HEADACHE, THE CATHETER WAS TIED OFF AND LEFT IN, UNATTACHED TO ANYTHING. A COMPLETELY NEW CATHETER WAS INSERTED AND ATTACHED TO THE PUMP. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL AND BUPIVACAINE. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention CATHETER: MODEL 8709SC| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 8840