BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4182345 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19939
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE 8596SC CATHETER REVEALED NON SIGNIFICANT INDENT IN SEAL, DID NOT AFFECT INFUSION. ANALYSIS OF THE 8598A CATHETER REVEALED CATHETER MISCELLANEOUS ACCEPTABLE TESTING, CATHETER INCOMPLETE/RETURNED IN SEGMENTS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE CATHETER. PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), EXPLANTED: 2014-(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

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

    Description of Event or Problem · 1

    AT THE END OF (B)(6) 2014, THE PATIENT STARTED TO LOSE THERAPY EFFECT WITH UNDERDOSE SYMPTOMS OF INCREASING SPASTICITY AND LESS THAN 50% THERAPY RELIEF. ON (B)(6) 2014, X-RAY SHOWED NO KINKS OR DISCONNECTIONS. A SINGLE BOLUS OF MEDICATION WAS PROGRAMMED AND WAS EFFECTIVE; THEREFORE, THE INFUSION RATE WAS INCREASED AT THAT TIME. THE PATIENT CONTINUED TO HAVE INEFFECTIVE THERAPY. ON (B)(6) 2014, BOTH A DYE AND ROTOR STUDY WAS PERFORMED WITH UNREMARKABLE RESULTS. THE HEALTHCARE PROFESSIONAL CONTINUED TITRATING THE INFUSION RATE UP; HOWEVER, THERAPY CONTINUED TO BE INEFFECTIVE. THE PATIENT WAS DUE FOR AN END OF LIFE BATTERY REPLACEMENT SO THE DECISION WAS MADE TO CHANGE THE CATHETER OUT AT THE SAME TIME. ON (B)(6) 2014, INTRAOPERATIVELY, THE NEUROSURGEON DISCONNECTED THE CATHETER FROM THE PUMP AT THE ABDOMINAL SITE AND THERE WAS NO RETROGRADE FLOW OF CEREBROSPINAL FLUID OBSERVED. THE CATHETER WAS DISCONNECTED AT THE SPINAL INCISION SITE AND THERE WAS NO RETROGRADE FLOW CEREBROSPINAL FLUID OBSERVED. THE NEUROSURGEON THEN PULLED THE SPINAL CATHETER OUT ONE INCH AND SAW RETROGRADE CEREBROSPINAL FLUID LEADING HIM TO BELIEVE THAT THE PATIENT HAD DEVELOPED EITHER A NEUROMA (GROWTH OF NERVE TISSUE) OR COMPARTMENTALIZATION WHICH CAUSED AN OCCLUSION AT THE CATHETER TIP. THE EXISTING CATHETERS WERE EXPLANTED AND A NEW CATHETER IMPLANTED. THE PATIENT¿S STATUS WAS REPORTED AS ¿ALIVE ¿ NO INJURY¿. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER RECEIVED REPORTED THE CLINICIAN STATED THE PATIENT WAS DOING WELL AND WAS RECEIVING EFFECTIVE THERAPY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661431 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR