BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2874681 · Received December 15, 2012

    Report

    Report Number
    3004209178-2012-11878
    Event Type
    Malfunction
    Date Received
    December 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MISSED A REFILL DUE TO THE NURSING HOME NOT BRINGING HER TO THE DOCTOR APPOINTMENT. THE REPORTER STATED THAT THE REFILL WAS MISSED BY ONE TO TWO DAYS. THE DATE OF THE EVENT WAS NOT PROVIDED. THE DEVICE SYSTEM WAS USED TO DELIVER 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 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1