BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5363766 · Received January 13, 2016

    Report

    Report Number
    3004209178-2016-00456
    Event Type
    Malfunction
    Date Received
    January 13, 2016
    Date of Event
    July 3, 2015
    Report Date
    December 17, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS IDENTIFIED THE PUMP MOTOR HAD A GEAR TRAIN ANOMALY; CORROSION AND/OR WEAR AND/OR LUBRICATION. THE STALL WAS DUE TO SHAFT-BEARING.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS RECEIVING BACLOFEN 500 MCG/ML; 136.64 MCG/DAY VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY AND CVA (STROKE) DAS SYSTEM. THE DATE OF THE EVENT WAS (B)(6) 2015. IT WAS REPORTED A MOTOR STALL OCCURRED (B)(6) 2015 13:10 AND MOTOR STALL RECOVERY OCCURRED (B)(6) 2015 13:47. SPECIFIC PATIENT SYMPTOMS, CAUSE OF THE EVENT, MEDICAL HISTORY, LOT NUMBER, THERAPY DATES AS WELL AS CONCOMITANT DRUGS AND PATIENT OUTCOME WERE NOT REPORTED; ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22699 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR