BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1934518 · Received November 23, 2010

    Report

    Report Number
    3004209178-2010-09889
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IN THE PAST MONTHS, THE PT HAD EXPERIENCED A RETURN OF PT SYMPTOMS/UNRELIEVED PAIN. THE ACTUAL RESIDUAL PUMP VOLUME (33 ML) WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME (2.9 ML). THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 82 YR EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N220664011