BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2113704 · Received June 2, 2011

    Report

    Report Number
    3007566237-2011-03924
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS SYNCHROMED II PUMP GENERATED AN AUDIBLE ALERT FOR MOTOR STALL WITH THE MESSAGE: "MOTOR STALL OCCURRED. STOPPED PUMP PERIOD MAY EXCEED TUBE SET." APPARENTLY, THE PUMP WAS STILL DISPENSING AND IT WAS ASSUMED TO BE A FALSE ALARM AS THE PATIENT REPORTED NO LOSS OF EFFECT. THE DRUG IN THE PUMP WAS MORPHINE 30 MG/ML, DELIVERING 12MG/24 HOURS, CATAPRESAN AND SALINE 0.9%. INITIALLY, THE HCP REFILLED THE PUMP EVERY THIRD MONTH. THEN THEY STARTED DOING IT EVERY 1.5 MONTHS. "IT STILL WORKED WELL WITH THE SHORTER REFILL INTERVAL". SINCE (B)(6) THE PROBLEM HAS ACCELERATED, AND THE PUMP ALARM IS NOW SOUNDING EVERY 6 MINUTES. INTERROGATION OF THE PUMP PROVED UNSUCCESSFUL. THE PUMP WAS EXPLANTED AND REPLACED ON (B)(6) 2011. THE CATHETER WORKS FINE WITH FREE BACKFLOW OF CSF (CEREBROSPINAL FLUID).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention