BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2543421 · Received April 20, 2012

    Report

    Report Number
    3004209178-2012-02550
    Event Type
    Injury
    Date Received
    April 20, 2012
    Report Date
    March 27, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL#8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: UNK. PROXIMAL CATHETER SEGMENT: MODEL# 8578, LOT# N113069, IMPLANTED: (B)(6) 2008, EXPLANTED: UNK. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN THE ICU AND WAS NOT ABLE TO TALK. THE HCP INTERROGATED THE PUMP AND THE PUMP SHOWED A REFILL DATE IN (B)(6). HCP DID NOT BELIEVE THE PATIENT'S STATUS WAS RELATED TO THE PUMP. THE PUMP WAS DELIVERING BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization