BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3252386 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12421
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    July 5, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1574-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8596SC LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER (B)(4). RETURNED FOR ANALYSIS THE PROXIMAL SEGMENT OF CATHETER MODEL 8596SC; ANALYSIS OF THIS REVEALED CORING-TEARS-CUTS IN THE SEAL OF THE SC CONNECTOR. UNDER MICROSCOPE INSPECTION A DEEP, CIRCULAR CORING WAS SEEN IN THE BOTTOM OF THE CUP OF THE SC CONNECTOR CONSISTENT WITH THE INNER DIAMETER OF THE TIP OF THE OUTLET PORT OF THE PUMP. THIS CORING IN THE SEAL PORTION AT THE BOTTOM OF THE CUP WAS CENTERED IN THE SEAL. PER ANALYSIS, THE FLAP OF MATERIAL CREATED BY THE CORING MAY HAVE CONTRIBUTED TO AN OCCLUSION BUT NO OCCLUSION WAS VERIFIED IN LAB TESTING. NO LEAKING WAS SEEN IN THE LAB TESTING EITHER. ALSO RETURNED WAS THE DISTAL SEGMENT OF CATHETER MODEL 8709SC; THAT REVEALED NO ANOMALIES, ACCEPTABLE CATHETER TESTING. THERE WAS A SMALL PORTION OF THE 8596SC THAT WAS PART OF THIS CATHETER BUT HAD NO ANOMALIES. RETURNED LATER WAS THE PUMP ON (B)(4) 2013; HOWEVER, THE 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 RETURNED PUMP REVEALED NO ANOMALY, NORMAL DEVICE FUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE MORNING OF (B)(6) 2013, PATIENT EXHIBITED SIGNS/SYMPTOMS OF INCREASED TONE, INCREASED HEART RATE, INCREASED TEMPERATURE, SWEATING, IRRITABILITY AND WAS ADMITTED AS AN INPATIENT. A CATHETER ACCESS PORT WAS ATTEMPTED ON (B)(6) 2013, BUT CLINICIAN WAS ONLY ABLE TO WITHDRAW NEGLIGIBLE AMOUNT OF FLUID; NO CHANGE IN PUMP PROGRAMMING SETTINGS. PATIENT WAS STARTED ON ORAL ANTISPASMODICS, BACLOFEN AND TRANXENE ADMINISTERED AND MONITORED UNTIL SURGERY FOR CATHETER REVISION PERFORMED. PATIENT UNDERWENT A CATHETER REPLACEMENT ON (B)(6) 2013. DURING REVISION SURGERY WHEN CATHETER DISCONNECTED FROM PUMP, IT WAS NOTED THERE WAS TISSUE INSIDE THE SUTURELESS CONNECTOR WEDGED UP AGAINST THE OPENING LEADING OUT TO THE CATHETER SEGMENT CAUSING AN OCCLUSION. AFTER THIS TISSUE WAS REMOVED, THE NEUROSURGEON WAS ABLE TO ASPIRATE FLUID FROM THE CATHETER VIA THE SUTURELESS CONNECTOR WITH A BLUNT NEEDLE ATTACHED TO A SYRINGE. ENTIRE EXISTING CATHETER SYSTEM EXPLANTED AND NEW CATHETER IMPLANTED. NEUROSURGEON FELT THAT THE WITHDRAWAL SYMPTOMS RELATED STRICTLY TO TISSUE OCCLUDING OUTFLOW OF MEDICATION FROM INSIDE SUTURELESS CONNECTOR INTO THE CATHETER. DRUG DELIVERED VIA THE DEVICE WAS GABLOFEN. ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT WAS RESPONDING TO THE THERAPY SINCE HER CATHETER REVISION AT THIS TIME; HOWEVER, REMAINS SUB THERAPEUTIC AS THE CLINICIANS ARE STILL INCREASING VIA TITRATION HER INFUSION RATE. IT WAS LATER REPORTED THAT PATIENT HAD INADEQUATE RESPONSE TO THERAPY SINCE CATHETER REVISION AND ON (B)(6) 2013 A CATHETER ACCESS, DYE STUDY AND ROTOR STUDY SHOWED PUMP FUNCTIONING PROPERLY AND CATHETER PATENT. ON (B)(6) 2013, A SINGLE 25 MCG BOLUS PROGRAMMED WITHOUT PATIENT EFFECT. CLINICIAN QUESTIONED IF PUMP WAS FILLED WITH ORDERED CONCENTRATION OF 1000 MCG/ML AT TIME OF CATHETER REVISION ON (B)(6) 2013, SO WITHDREW THE MEDICATION IN THE RESERVOIR -ACTUAL VOLUME 17 ML, WITH EXPECTED RESIDUAL VOLUME OF 14 ML. INTRAOPERATIVELY, PRIOR TO DISCONNECTING EXISTING CATHETER FROM EXISTING PUMP, CAP ACCESSED WITH 24 GAUGE NON-CORING NEEDLE AND EASILY WITHDREW CSF. WHEN DISCONNECTED EXISTING CATHETER FROM EXISTING PUMP, BRISK RETROGRADE FLOW CSF SEEN. AFTER REPLACEMENT WITH NEW PUMP AND CATHETER ATTACHED, CAP ACCESSED WITH 224 GAUGE NON-CORING NEEDLE AND EASILY WITHDREW CSF. NEW PUMP REFILLED WITH 1000 MCG/ML GABLOFEN AND RESTARTED AT 250 MCG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352518 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00005 YR