BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4662767 · Received April 6, 2015

    Report

    Report Number
    3004209178-2015-06032
    Event Type
    Malfunction
    Date Received
    April 6, 2015
    Report Date
    March 16, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-9, LOT# N240826, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709, LOT# J0056580R, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALARM WAS HEARD. TELEMETRY CONFIRMED THAT THE ALARM WAS DUE TO AN EMPTY RESERVOIR. A LOW RESERVOIR ALARM OCCURRED ON (B)(6) 2015 AND THE EMPTY RESERVOIR ALARM OCCURRED 3 DAYS LATER. THE PATIENT WAS ASYMPTOMATIC. THE DEVICE SYSTEM WAS USED TO DELIVER BUPIVACAINE, BACLOFEN, AND DILAUDID. THE CAUSE OF THE EVENT AND INTERVENTIONS/TREATMENT WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226448 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR