BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1061979 · Received June 16, 2008

    Report

    Report Number
    3004209178-2008-03265
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    February 1, 2008
    Report Date
    May 6, 2008
    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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: USED FOR THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A RETURN OF SYMPTOMS/SPASTICITY. THE PATIENT REPORTED HEARING A SOUND BUT NOT ONE SIMILAR TO THE ALARM TEST SOUND. THERE WERE NO ALARMS RECORDED IN THE LOGS AND THERE WAS NO SILENCE ALARM OPTION. THE PHYSICIAN PLANNED TO GIVE A 25 MCG BOLUS TO CHECK FOR EFFECT. THE CONCENTRATION AND DAILY DOSE OF BACLOFEN BEING ADMINISTERED VIA A PUMP WERE NOT REPORTED. IT WAS ALSO REPORTED THAT THE PATIENT HAD A URINARY TRACT INFECTION LEADING TO THE INCREASED SPASTICITY. A 25 MCG BOLUS WAS PROGRAMMED AND WITHIN 25 MINUTES, THE SPASTICITY STARTED TO DECREASE. THE PATIENT WAS GIVEN MEDICATION AND WAS SENT HOME. THE NURSE REPORTED THE FOLLOWING DAY THAT THE PATIENT WAS DOING WELL. IT WAS LATER REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT FOLLOWING A NEW PUMP AND CATHETER IMPLANT. NO ALARMS WERE HEARD AT THE TIME OF THIS REPORT. RESERVOIR VOLUMES MEASURED EQUALLY. THE INTRATHECAL DRUG PRESCRIPTION WAS CONFIRMED AND THE CORRECT CONCENTRATION, DRUG, AND DOSE WERE PROGRAMMED. A DYE STUDY WAS ATTEMPTED; THE CATHETER WAS ASPIRATED BUT ONLY .4CC OF PINK FLUID AND AIR BUBBLES WERE OBTAINED. THE HCP ATTEMPTED TO DELIVER THE DYE DESPITE THE INABILITY TO ASPIRATE. HE WAS UNABLE TO PUSH OR PULL FLUID VIA THE CATHETER ACCESS PORT WITH A 25G NEEDLE. FINAL OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| CATHETER MODEL 8711 LOT# N131829006| IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNKNOWN