BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2395076 · Received January 3, 2012

    Report

    Report Number
    3007566237-2012-00004
    Event Type
    Injury
    Date Received
    January 3, 2012
    Date of Event
    December 7, 2011
    Report Date
    December 7, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    CONCOMITANT MEDICAL PRODUCTS: CATHETER MODEL 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2011. 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.

    Additional Manufacturer Narrative · 1

    CORRECTION MADE TO REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED CATHETER SEGMENTS REVEALED THE CATHETER/PUMP CONNECTOR/SC CONNECTOR WAS DAMAGED AT EXPLANT.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD BEEN RECEIVING EFFICACIOUS THERAPY UNTIL (B)(6) 2011, WHEN ADMITTED TO ER WITH SYMPTOMS OF INCREASED SWEATING, INCREASED TONE AND INCREASED AGITATION. X-RAYS WERE DONE ON THE SAME DAY AND NOTHING REMARKABLE WAS OBSERVED. CAP (CATHETER ACCESS PORT) STUDY WAS ATTEMPTED THE NEXT DAY AND THE CLINICIAN WAS UNABLE TO ASPIRATE ANYTHING FROM CATHETER. A CATHETER REVISION WAS DECIDED UPON AND WAS DONE ON (B)(6). DRUG DELIVERED VIA THE DEVICE WAS GABLOFEN, CONCENTRATION 1000 MCG/ML, RATE OF INFUSION 315 MCG/DAY. DURING SURGERY, AN INCISION WAS MADE AT THE PUMP POCKET SITE AND WHEN THE CATHETER WAS DISCONNECTED FROM PUMP IT WAS OBSERVED THAT THERE WAS NO RETROGRADE FLOW OF CEREBRAL SPINAL FLUID (CSF). NEXT, AN INCISION WAS MADE AT SPINAL SITE, CATHETER WAS CUT AND EXPOSED AND AN IMMEDIATE RETROGRADE FLOW OF CSF FROM THE SPINAL SEGMENT WAS NOTED. BASED ON THESE OBSERVATIONS, PHYSICIAN CHOSE TO REPLACE SEGMENT OF CATHETER RUNNING FROM SPINE TO THE ABDOMINAL PUMP POCKET. SYSTEM WAS PRIMED FOR NEW CATHETER LENGTH ONLY AS SPINAL SEGMENT WAS CLEARED OF MEDICATION AS WELL AS NEWLY IMPLANTED PROXIMAL SEGMENT. INFUSION RATE DECREASED TO 150MCG/DAY. WHEN THE PUMP WAS RESTARTED AFTER CATHETER REVISION THE INFUSION RATE WAS DECREASED FROM SIMPLE CONTINUOUS INFUSION RATE OF 315MCG/DAY DOWN TO A SIMPLE CONTINUOUS INFUSION RATE OF 75MCG/DAY. PATIENT SUSTAINED NO INJURY. IT WAS LATER REPORTED THAT A CATHETER DYE STUDY WAS NOT PERFORMED PRIOR TO CATHETER REVISION, AND IT WAS NOT EVIDENT DURING SURGERY WHERE THE CATHETER WAS OCCLUDED. PER THE REPORTER, THE NEUROSURGEON MADE THE ASSUMPTION THE CATHETER WAS OCCLUDED IN THE PROXIMAL SEGMENT BASED ON HIS FINDINGS INTRA-OPERATIVELY. FOLLOWING CATHETER REVISION, PATIENT WAS ADMITTED FOR TITRATION AND OBSERVATION. FROM HER INFUSION RATE OF 75MCG/DAY ON (B)(6), HER INFUSION RATE WAS QUICKLY TITRATED UP. PATIENT WAS SEEN BY THE MANAGING PHYSICIAN MOST RECENTLY ON (B)(6) 2011. SHE WAS DOING WELL AT THAT TIME AND HER INFUSION RATE WAS GABLOFEN (1000 MCG/ML) AT 315.6 MCG/DAY, WHICH WAS HER INFUSION RATE PRIOR TO HER MOST RECENT SURGERY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASED TONE IN ALL EXTREMITIES, SWEATING HANDS, DECREASED AROUSAL AND INCREASED CLONUS. THE OUTCOME WAS REPORTED AS RESOLVED WITHOUT SEQUELAE ON (B)(6)-2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR Required Intervention