BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1935964 · Received December 3, 2010

    Report

    Report Number
    3004209178-2010-10158
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 23, 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
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "BAFFLES" OF THE PUMP STOPPED WORKING; THE PUMP WASN'T WORKING. THE PT HAD HAD MORPHINE IN THE PUMP; IT WAS SWITCHED TO DILAUDID. IT WAS STATED THAT "MAYBE THE MORPHINE DID WORK; IT WAS THE PUMP THAT JUST WASN'T WORKING." ADDITIONAL INFORMATION HAS BEEN REQUESTED; A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR PROGRAMMER: MODEL 8835, LOT# NPG016043N| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N228587| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N237730004