BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1924834 · Received December 7, 2010

    Report

    Report Number
    3004209178-2010-10301
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT EXPERIENCED A CHANGE IN THERAPY EFFECT WITH HEADACHE AND INCREASED "NERVE PAIN". THE EVENT OCCURRED FOLLOWING A REFILL SESSION. THE HCP HAD CHANGED THE DRUG CONCENTRATION TO SEE IF THAT HELPED WITH THE HEADACHE WHICH WAS NOTED FOR 10 DAYS FOLLOWING EVERY REFILL. THE PT HAD HAD BLOOD PATCHES WITH NO RESULT; DATE NOT SPECIFIED. IT WAS LATER REPORTED THAT THERE WERE NO PROBLEMS NOTED WITH THE DEVICE; THIS WAS CONFIRMED BY X-RAY. THE PT CONTINUED TO HAVE SOME DIFFICULTIES; A DYE STUDY WAS PLANNED FOR (B)(6) 2010 TO POSSIBLY RULE OUT ANY DEVICE ISSUES. AT THE TIME OF THIS REPORT, THE PT WAS RECEIVING SOME BENEFIT FROM THE PUMP. IT WAS LATER REPORTED THAT THE DYE STUDY WENT WELL AND NO DEVICE ISSUES WERE NOTED; IT WAS CONCLUDED THAT THE EVENT WAS NOT RELATED TO THE DEVICE. THE PT WAS CURRENTLY FINE. AS OF A REPORT (B)(6) 2010, THE PT RECENTLY EXPERIENCED INCREASED PAIN AND SPASTICITY. AN AP/LATERAL X-RAY WAS DONE, AS WELL AS A CATHETER ACCESS DYE STUDY. BOTH OF THOSE TESTS PROVED NEGATIVE AND A CEREBROSPINAL FLUID ASSAY WAS DRAWN ON (B)(6) 2010, WHICH SHOWED LOW LEVELS OF BACLOFEN IN THE CEREBROSPINAL FLUID. THE PT HAD BEEN RECEIVING ORAL BACLOFEN, BUT WAS HAVING SEVERE SPASMS. THE DECISION WAS MADE TO DO A CATHETER AND PUMP REPLACEMENT ON (B)(6) 2010. UPON OPENING THE SPINAL INCISION AND THE PUMP INCISION SITES, THE NEUROSURGEON COULD SEE NO EVIDENCE OF CATHETER KINK; THE CATHETER APPEARED TO BE PATENT AND INTACT. DUE TO THE PT'S SYMPTOMS, THE ENTIRE SYS WAS REPLACED. THE PT WAS ON LIORESAL AT A CONCENTRATION OF 1,000 MCG/ML IN FLEX DOSING, FOR A TOTAL OF 222.9 MCG PER DAY. SHE WAS RESTARTED ON LIORESAL 500 MCG/ML CONCENTRATION AT AN INFUSION RATE OF 75 MCG PER DAY IN SIMPLE, CONTINUOUS INFUSION MODE FOLLOWING REPLACEMENT OF THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention IMPLANTED:| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8711, LOT# J11192R05| IMPLANTED:| CATHETER: MODEL 8596, LOT# N082865015