BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4243878 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21344
    Event Type
    Injury
    Date Received
    November 11, 2014
    Report Date
    October 24, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED PUMP MOTOR GEAR TRAIN ANOMALIES. THESE INCLUDED CORROSION AND/OR WEAR AND/OR LUBRICATION AND STALL DUE TO SHAFT-BEARING.

    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 AN ALARM FOR A CRITICAL MOTOR STALL OCCURRED. IT WAS UNKNOWN IF THE MOTOR STALL HAD RECOVERED. THE PUMP WAS EXPLANTED AND REPLACED. THE REPORTED STATED "IN [THEIR] OPINION, THE CAUSE OF THE ROTOR STALL [WAS] THE MEDICATION WHICH WAS USED IN THE PUMP". THE PATIENT'S SYMPTOMS WERE LISTED AS UNDERDOSE SYMPTOMS. IT WAS UNKNOWN HOW THE PATIENT WAS DOING FOLLOWING THE REPLACEMENT. THE PUMP WAS USED TO DELIVER CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725460 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention