BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3840615 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09892
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1570-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO ANOMALY. AS RECEIVED THE PUMP RESERVOIR HAD 35 MILLILITERS OF FLUID IN IT AND WAS IN STOPPED PUMP INFUSION MODE. THE PUMP LOGS INDICATED A MOTOR STALL RECOVERY AND STOPPED PUMP PERIOD MAY EXCEED TUBE SET. THE TUBE SET WAS BECAUSE THE PUMP WAS PROGRAMMED TO STOPPED PUMP MODE. THE MOTOR STALL RECOVERY INDICATES THAT DURING THE PUMP LIFE THE PUMP EXPERIENCED A MOTOR STALL AND MOTOR STALL RECOVERY. THE PUMP PASSED ALL ACCURACY TESTING AND WAS SUBJECTED TO FURTHER CHARACTERIZATION INFUSION TESTING. DESTRUCTIVE ANALYSIS REVEALED NO ANOMALIES. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, THE PHYSICIAN REFILLED THE PATIENT¿S BACLOFEN PUMP. LATER IN THE DAY, THE PATIENT PRESENTED AT AN ACCIDENT AND EMERGENCY DEPARTMENT WITH SYMPTOMS OF OVERDOSING OF BACLOFEN. IT WAS UNKNOWN IF THERE WAS PATIENT INJURY. THE PHYSICIAN WANTED THE PUMP SET TO MINIMUM RATE AND THAT OCCURRED. THE PUMP WAS REPLACED ON (B)(6) 2014 AND THE PATIENT¿S STATUS WAS REPORTED AS FULLY RECOVERED. THE REASON FOR THE REMOVAL OF THE PUMP WAS POTENTIAL OVERDOSING OF THE PUMP. IT WAS FURTHER PROVIDED THAT THE PATIENT WAS BEING DELIVERED 1000 MICROGRAMS PER MILLILITER (ML) OF BACLOFEN AND 15 MILLIGRAMS PER ML OF MORPHINE SULPHATE. THE CAUSE OF THE ISSUE WAS NOT ESTABLISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319088 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention