BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3063243 · Received April 17, 2013

    Report

    Report Number
    3004209178-2013-06432
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 20, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8590-1 LOT# N316647, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8840 LOT# SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REFILL ON MONDAY (B)(6) 2013 AND THE HEALTHCARE PROVIDER (HCP) FORGOT TO UPDATE THE RESERVOIR VOLUME. THE PUMP WAS CURRENTLY ALARMING AND TELEMETRY CONFIRMED A NON-CRITICAL ALARM DUE TO LOW RESERVOIR VOLUME REACHED. THE CALLER WAS TO UPDATE THE PUMP TO THE CURRENT RESERVOIR VOLUME. NO PATIENT SYMPTOMS REPORTED. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. IT WAS LATER REPORTED THAT THE PATIENT WAS MET WITH AND TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED "EVERYTHING IS FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166090 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1