BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2023111 · Received February 24, 2011

    Report

    Report Number
    3004209178-2011-01392
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 14, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INCREASE IN PAIN IN HER HIPS. A VOLUME DISCREPANCY WAS NOTED; THE ACTUAL RESIDUAL VOLUME OF 25 ML WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME OF 4.9 ML. THE PUMP CONTAINED MORPHINE AND BUPIVICAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP 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 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8575, LOT# N151971| CATHETER: MODEL 8709, LOT# J11148R19| EXPLANTED: