BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4292083 · Received December 2, 2014

    Report

    Report Number
    3004209178-2014-22423
    Event Type
    Malfunction
    Date Received
    December 2, 2014
    Date of Event
    October 17, 2014
    Report Date
    November 5, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. PRODUCT ID: 8 590-1, LOT# N252645, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CRITICAL PUMP ALARM DUE TO ZERO ML RESERVOIR VOLUME REACHED WAS HEARD AND WAS CONFIRMED BY TELEMETRY. THE PATIENT WAS NEW TO THE DOCTOR¿S CARE. THE PATIENT PRESENTED TO THE CLINIC ON (B)(6) 2014 AND THE PUMP WAS EMPTY. PUMP LOGS SHOWED THAT THE PUMP WENT EMPTY ON (B)(6) 2014. THE PATIENT HAD NO SYMPTOMS OF WITHDRAWAL AND THE FAMILY WAS REPORTING NO CHANGE IN BASELINE. THE PHYSICIAN WAS ¿THEORIZING¿ A CATHETER ISSUE AND PLANNED TO DO IMAGING AND A DYE STUDY BECAUSE HE EXPECTED THE PATIENT TO HAVE SYMPTOMS IF THE PUMP WAS EMPTY. THE PHYSICIAN WAS TO FILL THE PUMP ON (B)(6) 2014 AND THEN DO TROUBLESHOOTING OF THE SYSTEM TO MAKE SURE THE PATIENT WAS GETTING DRUG. THE DEVICE SYSTEM DELIVERED GABLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN NEW INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778923 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 YR