BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3821719 · Received May 20, 2014

    Report

    Report Number
    3007566237-2014-01369
    Event Type
    Injury
    Date Received
    May 20, 2014
    Report Date
    April 30, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE RESULTS OF THE MYELOGRAM SHOWED THE CATHETER "HAIRPIN TURN CATH PATENT" BUT REQUIRED FORCE TO INJECT DYE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VOLUME DISCREPANCY OCCURRED. THE ACTUAL RESERVOIR VOLUME (ARV) WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME (ERV). THE SPECIFIC VOLUMES WERE NOT PROVIDED. IT WAS NOTED THAT THE PATIENT HAD INTERMITTENT VOLUME DISCREPANCIES AT THE PAST FEW REFILLS. THE PATIENT HADN¿T BEEN GETTING GOOD THERAPY FOR THE PAST 2 MONTHS. PER AN X-RAY, IT LOOKED LIKE THE CATHETER WAS KINKED INTRATHECALLY. A CATHETER REVISION WAS TO BE DONE ON THE REPORT DATE. IT WAS NOTED THAT THE PATIENT WOULD BE IN THE HOSPITAL INTENSIVE CARE UNIT (ICU) POST-SURGERY FOR 3 DAYS BECAUSE THEY WERE DECREASING THE DOSING FROM 1762MCG/DAY TO 150MCG/DAY. VALIUM AND ORAL BACLOFEN WOULD BE AVAILABLE AS NEEDED. THE PATIENT HAD BEEN TAKING ORAL BACLOFEN. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENT SPASTICITY AND MORE TIME SPASTIC THAN FLACCID. ON AND OFF HIGH RESIDUAL VOLUMES OCCURRED. THE CAUSE OF THE DISCREPANCY WAS ¿CATHETER OUTFLOW RESISTANCE OR SOMETHING ELSE¿. THE LOCATION OF THE CATHETER KINK WAS AT T10. IT WAS ALSO REPORTED THAT THE CATHETER ENTERED AT L2/L3. AT T10, IT LOOPED BACK, FACING CAUDAL. THE DOSE WAS INCREASED WITH INTERMITTENT RESPONSE AND MORE SPASTICITY. THE DRUG WAS COMPOUNDED TO INCREASE CONCENTRATION. DUE TO DIFFICULTY IN ACHIEVING SPASTICITY, A ¿CAUDAL¿ SIDE PORT MYELOGRAM¿ WAS DONE. THE CATHETER WAS INTACT WITH HIGH RESISTANCE, BUT THE HEALTHCARE PROVIDER (HCP) WAS ABLE TO DO THE INJECTION. THE CATHETER WAS FACING CAUDAL AT T10. THE DOSE WAS INCREASED TO ¿1700 OR SO¿. BOLUSES WERE INCREASED AND THE PATIENT WAS STILL TAKING ORAL MEDICATION AND WAS SPASTIC. THE PATIENT WAS REFERRED BACK TO A NEUROSURGEON. THE PATIENT WAS REVALUATED AND FOUND THE PATIENT FLACCID AFTER BOLUSES. THE PATIENT STILL COMPLAINED SO THE CATHETER WAS REVISED IN (B)(6) 2014. THE CATHETER WOULD NOT GO BEYOND ¿L1L2 ENTRY L3L4¿. THE PATIENT WAS ADMITTED AND STARTED AT 150MCG/DAY. AT THE TIME OF THIS REPORT, THE HCP WAS TITRATING IT UP TO 400 OR LESS PER DAY ¿AT LAST CHANGE¿. IT WAS NOTED THAT MULTIPLE SURGERIES WOULD BE NEEDED TO REVISE THE CATHETER, AS THE PATIENT WAS OSSIFIED AND NEEDED A LAMINOTOMY TO INSERT THE CATHETER. PLEASE SEE MANUFACTURER REPORT # 3007566237-2010-02056 FOR EVENTS OCCURRING PRIOR TO THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298749 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00033 YR Hospitalization| R