BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2181401 · Received July 21, 2011

    Report

    Report Number
    3004209178-2011-05625
    Event Type
    Injury
    Date Received
    July 21, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNDERDOSE. A DYE STUDY WAS PERFORMED, BUT THEY COULD NOT ASPIRATE THE CATHETER SO A REVISION WAS DONE ON (B)(6) 2011. THE SURGEON HAD DIFFICULTY TAKING THE SC CONNECTOR AND DISCONNECTING IT FROM THE PUMP. THE METAL PIECE ON THE INSIDE OF SC CONNECTOR SEEMED TO BE STAYING ON THE PUMP. THEY CHECKED FOR CEREBROSPINAL FLUID (CSF) BACKFLOW AT VARIOUS SPOTS ALONG THE CATHETER AND IT WAS DECIDED WHEN THEY DID NOT RECEIVE FLOW TO PULL THE INTRATHECAL END OF THE CATHETER OUT OF SPINAL COLUMN. AFTER PULLING QUITE A BIT BACK THE PHYSICIAN DID SEE CSF AND ENTERED A NEW CATHETER AT ONE VERTEBRAL LEVEL HIGHER DUE TO SOME RESISTANCE MET AT PREVIOUS ENTRY SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731SC, LOT# N246341004