BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3070709 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06632
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8780 LOT# SERIAL# (B)(4) IMPLANTED: 2013 (B)(6) PRODUCT TYPE CATHETER PRODUCT ID: 87 09SC LOT# SERIAL# (B)(4) IMPLANTED: 2012 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THERE WAS A DURA-LEAK WITH AN UNKNOWN CAUSE AND A VISIBLE POCKET OF FLUID AT THE SPINAL ENTRY POINT; THERE WAS A SIGNIFICANT AMOUNT OF FLUID FOLLOWING THE CATHETER TRACK TO THE PUMP POCKET AND FILLING THE POCKET (DATE OF ONSET NOT REPORTED). IN THE PROCESS OF INVESTIGATING A DURA LEAK, THE CATHETER WAS CUT BY MISTAKE, THEREFORE NEEDED REPLACEMENT; "THEY WERE GOING IN TO DO A PATCH AND WHEN THE HEALTHCARE PROVIDER CUT THE CATHETER BY ACCIDENT". ON THE DATE OF THIS REPORT THE CATHETER WAS SPLICED AND A NEW CATHETER WAS PLACED IN THE INTRATHECAL SPACE AND CONNECTED TO THE EXISTING CATHETER. THE EXPLANTED CATHETER SEGMENT WAS NOT TO BE RETURNED AS IT WAS DISCARDED. PATIENT SYMPTOMS INCLUDED HEADACHE; PATIENT STATUS AT TIME OF THIS REPORT ALIVE WITH NO INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD APPROXIMATELY 100 CCS OF CLEAR FLUID AROUND THE PUMP POCKET. THE HEALTH CARE PROVIDER REPORTEDLY BELIEVED IT WAS CEREBROSPINAL FLUID (CSF) AS THE PATIENT HAD A CATHETER REVISION DONE ON (B)(6) 2013 FOR THE SAME ISSUE AFTER THE CATHETER HAD BEEN CONFIRMED PATENT WITH A DYE STUDY. THE FLUID WAS WITHDRAWN AND THE REPORTER BELIEVED IT WAS SENT OFF FOR TESTING. THE FLUID APPEARED TO BE CLEAR, CSF LIKE MATERIAL. IT WAS NOTED THE PATIENT DID NOT HAVE POSITIONAL HEADACHES AND WAS GETTING GOOD THERAPY AND PAIN RELIEF. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172168 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention