BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3120892 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07942
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8703W LOT# SERIAL# (B)(4), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND IT PASSED ALL NON-DESTRUCTIVE TESTING. NO ANOMALY WAS FOUND. ANALYSIS OF THE CATHETER NOTED IT WAS RETURNED IN THREE SEGMENTS. THERE WERE SUTURES OBSERVED DIRECTLY ON THE CATHETER BODY AT BOTH ENDS OF THE PIN CONNECTOR OF SEGMENT 3. IT WAS NOTED THAT THE CATHETER BODY/CATHETER WAS INCORRECTLY ASSEMBLED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY DEPLETED IN THIS PUMP AND IT WAS EXPLANTED. DURING SURGERY, THE CATHETER HAD POOR CEREBRAL SPINAL FLUID (CSF) FLOW. AN OCCLUSION WAS REPORTED, ALTHOUGH, IT WAS UNKNOWN WHERE IN THE CATHETER. NO SYMPTOMS WERE REPORTED AND THERE WAS NO PATIENT INJURY. THE CATHETER AND PUMP WERE REPLACED. THIS DEVICE SYSTEM DELIVERED LIORESAL.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT DURING THE DEVICE IMPLANT, THE SURGEON TRIMMED THE PUMP CONNECTOR OFF, THEN IT WAS NOTED THE SURGEON HAD LIMITED SUPPLIES OF CATHETERS. TROUBLESHOOTING WAS PERFORMED AND IT WAS DISCUSSED THAT THE PUMP CONNECTOR THAT WAS CUT OFF MAY BE ABLE TO BE USED AND ANOTHER CATHETER SEGMENT COULD BE CONNECTED USING A PIN. ADDITIONAL INFORMATION RECEIVED REPORTED THE DRUG IN THE PUMP WAS GABLOFEN. THE CAUSE OF THE EVENT WAS NOTED TO BE DUE TO THE CATHETER WAS CUT AT THE PROXIMAL END DUE TO POOR FLOW AND THE NEED FOR A NEW CONNECTOR (AS PREVIOUSLY REPORTED). IT WAS NOTED THAT WHEN THE SURGEON CUT THE PROXIMAL END OF THE CATHETER, THEY DID NOT HAVE THE CORRECT CONNECTOR ON HAND. THE SURGEON THEREFORE ENDED UP REPLACING THE CATHETER DUE TO POOR FLOW OF THE EXISTING CATHETER (AS PREVIOUSLY REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222260 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR