BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6133333 · Received November 29, 2016

    Report

    Report Number
    3004209178-2016-24853
    Event Type
    Injury
    Date Received
    November 29, 2016
    Date of Event
    November 9, 2016
    Report Date
    December 28, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    UDI-DI
    00643169100831
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. 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

    UPDATE/CORRECTION: THE PREVIOUS REPORT (INITIAL REPORT) INDICATED (B)(6) 2016 VERSUS (B)(6) 2016 IN ERROR REGARDING THE DATE OF EVENT.

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. ANALYSIS OF THE CATHETER IDENTIFIED DAMAGE TO THE TRANSITION TUBING. IT WAS NOTED THAT THE PORTION OF THE TRANSITION TUBING BENEATH THE STRAIN RELIEF SHROUD WAS INTACT AND UNAFFECTED BY THE TEARING SEEN EXTERNAL TO THE STRAIN RELIEF SHROUD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING BACLOFEN WITH CONCENTRATION 1000.0 MCG/ML AT A SIMPLE CONTINUOUS DOSE RATE OF 164.8 MCG/DAY VIA AN IMPLANTABLE PUMP AS OF (B)(6) 2016 FOR CEREBRAL PALSY AND INTRACTABLE SPASTICITY. IT WAS REPORTED AS PER THE PATIENT¿S MANAGING PHYSICIAN DOSE INCREASES WERE MADE, HOWEVER, THE PATIENT WAS NOT GETTING THERAPEUTIC RESULTS. SLUGGISH ASPIRATION OCCURRED REGARDING A DYE STUDY PERFORMED ON (B)(6) 2016. THE PHYSICIAN DECIDED TO SEND THE PATIENT FOR SURGICAL EXPLORATION ON (B)(6) 2016. THE PUMP POCKET WAS OPENED AND THE SURGEON WAS ABLE TO ASPIRATE FROM THE CATHETER ACCESS PORT (CAP). THE CATHETER WAS REMOVED FROM THE PUMP CONNECTOR AND A RETURN OF CEREBROSPINAL FLUID WAS NOTED. THE SURGEON WAS NOT GOING TO DO ANY FURTHER INTERVENTION, BUT THEN NOTICED FRAYING ON THE CATHETER. REGARDING THE FRAYING, IT WAS NOTED THAT THEY WERE NOT SURE IF IT WAS WHERE THE COLLET WAS LAYING ON THE CATHETER SINCE IT WAS COILED. THE CATHETER WAS REVISED ON (B)(6) 2016 DUE TO FRAYING. AS PER THE PUMP¿S LOG, 12 CM WERE REMOVED FROM THE SPINAL CATHETER SEGMENT AND A NEW PUMP SEGMENT WAS PLACED. THE CATHETER WAS RETURNED FOR ANALYSIS; RECEIVED 2016-NOV-16. IT WAS NOTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE CAUSE OF THE FRAYED AND COILED CATHETER WAS NOT DETERMINED. THE ISSUE WAS RESOLVED AS OF (B)(6) 2016. THE PATIENT WAS WITHOUT INJURY REGARDING THEIR STATUS AS OF (B)(6) 2016. OTHER MEDICATIONS (ORAL, ETC.) THE PATIENT WAS RECEIVING AT THE TIME OF THE EVENT WERE UNABLE TO BE OBTAINED. THE PATIENT¿S MEDICAL HISTORY INCLUDED CEREBRAL PALSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784105 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20 00643169100831

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention