BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2181580 · Received July 5, 2011

    Report

    Report Number
    3004209178-2011-05106
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 12, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTED "CHANGE IN THERAPY EFFECT." HE "DOESN'T FEEL LIKE PUMP IS WORKING CORRECTLY." 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
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N279904003| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 8591, LOT# C80731