BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3559511 · Received January 7, 2014

    Report

    Report Number
    3007566237-2014-00066
    Event Type
    Injury
    Date Received
    January 7, 2014
    Date of Event
    April 1, 2008
    Report Date
    December 12, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_CATH, LOT# UNKNOWN, IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4). WAS NOT POSSIBLE TO MATCH THIS EVENT TO A PREVIOUSLY REPORTED EVENT. ACTUAL EVENT DATE WAS UNKNOWN. THE DATE IS BASED ON THE APPROXIMATE DATE OF ONSET OF SYMPTOMS 9 DAYS PRIOR TO THE REPLACEMENT OF THE CATHETER (DAY AND MONTH UNKNOWN). ACTUAL IMPLANT DATE AND EXPLANT DATE WERE UNKNOWN. THE IMPLANT DATE WAS REPORTED AS APRIL, 2004 AND EXPLANT WAS 5 YEARS 7 MONTHS FOLLOWING IMPLANT. ACTUAL CATHETER IMPLANT AND EXPLANT DATE WERE UNKNOWN. THE EXPLANT DATE WAS APPROXIMATELY 4 YEARS AFTER INITIAL IMPLANT DATE OF APRIL, 2004.

    Description of Event or Problem · 1

    STETKAROVA, I. [LONG-TERM TREATMENT WITH INTRATHECAL BACLOFEN IN A MULTIPLE SCLEROSIS PATIENT: A CASE REPORT.] CESKA LOV NEUROL NEUROCHIR. 2013:76(1);1S15-1S17. SUMMARY: INTRATHECALLY-ADMINISTERED BACLOFEN DELIVERED BY PUMP SYSTEMS IS THE METHOD OF CHOICE FOR PATIENTS WITH SEVERE GENERALIZED SPASTICITY WHEN OTHER METHODS OF TREATMENT HAVE BEEN UNSUCCESSFUL. IN THIS PAPER, WE REPORT UPON THE SUCCESSFUL OUTCOMES OF TEN YEARS OF TREATMENT OF SEVERE GENERALIZED SPASTICITY WITH BACLOFEN PUMP IN A MULTIPLE SCLEROSIS PATIENT. A 58-YEAR-OLD FEMALE PATIENT WITH MULTIPLE SCLEROSIS IN SECONDARY PROGRESSION WAS REFERRED TO OUR OUTPATIENT SURGERY FOR THE TREATMENT OF SEVERE SPASTICITY OF THE LOWER EXTREMITIES. THE DIAGNOSIS OF MULTIPLE SCLEROSIS WAS BASED ON THE TYPICAL CLINICAL STATUS, MAGNETIC RESONANCE FINDINGS AND LIQUOR FINDINGS. AT THE TIME OF ITB TESTING, THE MS PATIENT HAD EDSS OF 7. SHE WAS TAKING HIGH-DOSE ANTISPASMODIC ORAL MEDICATION. FOLLOWING POSITIVE CLINICAL RESPONSE TO ITB, SHE UNDERWENT THE FIRST PUMP IMPLANTATION (SYNCHROMED EL, MEDTRONIC) IN 2004 WITH A VERY GOOD EFFECT UPON THE REDUCTION OF HYPERTONIC MUSCLE CONDITION AND DECREASED FREQUENCY OF MUSCLE SPASMS. AFTER FOUR YEARS FROM IMPLANTATION, THE CATHETER SUDDENLY GOT BLOCKED AND REPLACEMENT WAS NECESSARY. AT THE END OF THE PUMP GENERATOR¿S LIFE AFTER MORE THAN FIVE YEARS FROM IMPLANTATION, THE OLD PUMP WAS REPLACED WITH A NEW ONE (SYNCHROMED II, MEDTRONIC). THE PATIENT HAS BEEN SATISFIED LONG-TERM WITH THE DAILY DOSE OF 125 G OF BACLOFEN. HER CURRENT EDSS IS 7.5. CONTINUAL INTRATHECAL BACLOFEN DELIVERY IS THE TREATMENT OPTION OF CHOICE IN PATIENTS WITH SEVERE GENERALIZED SPASTICITY THAT LIMITS THEIR SELF-SUFFICIENCY AND DAILY LIFE, AS SHOWN IN OUR MS PATIENT WHO HAS BEEN STABLE FOR 10 YEARS OF ITB TREATMENT. THE COMPLICATIONS OF ITB ARE USUALLY MORE MINOR AND EASY TO TREAT. REPORTED EVENT: A 58-YEAR-OLD FEMALE PATIENT WITH MULTIPLE SCLEROSIS EXPERIENCED A SUDDEN WORSENING OF SPASTICITY 4 YEARS AFTER IMPLANT. THE PATIENT COMPLAINED OF VERTIGO, NAUSEA AND PSYCHOMOTORIC UNREST. X-RAY IMAGING DID NOT REVEAL ANY CATHETER FAILURE, AND THE ROTOR TEST PROVED THAT THE PUMP WAS FUNCTIONING NORMALLY. ADMINISTRATION OF CONTRAST BOLUS THROUGH THE SIDE PORT OF THE PUMP WAS UNSUCCESSFUL AND CATHETER BLOCKING WAS THUS SUSPECTED. THE PATIENT RECEIVED ORAL BACLOFEN DOSES OF 100¿150 MG DAILY TO BRIDGE THE ABSTINENCE EFFECTS OF THE SUDDEN INTERRUPTION OF DRUG ADMINISTRATION. THE CATHETER WAS REPLACED NINE DAYS FROM THE FIRST OCCURRENCE OF THE SYMPTOMS. SPASTICITY WAS REDUCED CONSIDERABLY 24 HOURS FROM THE ADJUSTMENT OF THE SPINAL SECTION OF THE CATHETER. THE PATIENT WAS AGAIN SATISFIED WITH 120 G OF BACLOFEN DAILY. SHE EXPERIENCED NO OTHER COMPLICATIONS CONNECTED WITH THE PUMP SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10444 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8626 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention