BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3120404 · Received May 20, 2013

    Report

    Report Number
    3007566237-2013-01675
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A ROUTINE PUMP REFILL WITHOUT ANY CHANGES PROGRAMMED. THE PROCEDURE WAS DONE BY THE MOST EXPERIENCED PERSONNEL IN THE CLINIC WITHOUT PROBLEMS. THE FOLLOWING DAY, THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT WITH ALTERED MENTAL STATUS AND HYPOTENSION. THE PATIENT WAS REPORTEDLY NEARLY COMATOSE AND REQUIRED INTUBATION. NO SEIZURE ACTIVITY WAS OBSERVED. IT WAS REPORTED URINE DRUG MONITORING WAS NEGATIVE, THERE WERE NO SIGNS OR SYMPTOMS OF INFECTION, HEAD CT WAS NEGATIVE AND ALL BLOOD WORK WAS NEGATIVE. THE PUMP WAS IMMEDIATELY INTERROGATED, BUTNO ERRORS/EVENTS WERE NOTED. THE DAILY DOSE WAS DECREASED BY SIXTY FIVE PERCENT. THE PATIENT THEN IMPROVED ENOUGH TO BE EXTUBATED LATER BUT REMAINED EXTREMELY SOMNOLENT AND DROWSY. THE PATIENT HAD A PROFOUND DECREASE IN MUSCLE TONE AND THE PUMP WAS REPROGRAMMED TO AN EVEN LOWER DAILY DOSE OF 80 MCG PER DAY. AN MRI OF THE HEAD AND BRAINSTEM WAS POSITIVE WITH FINDINGS CONSISTENT WITH MULTIPLE SCLEROSIS, WHICH WERE NOT NEW. THE PUMP WAS FINALLY EMPTIED AND WAS FOUND TO HAVE 6 MILLILITERS LESS IN THE RESERVOIR THAN WHAT WAS INDICATED IN THE INTERROGATED SETTINGS. THE PUMP WAS PROMPTLY REPLACED. THE PATIENT REMAINED INTUBATED OVERNIGHT. THE PATIENT WAS THEN SUCCESSFULLY EXTUBATED AND HAD MARKED IMPROVEMENT IN HER MENTAL STATUS. THE DEVICE SYSTEM HAD BEEN USED TO DELIVER BACLOFEN AND CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221915 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R