BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1822445 · Received August 26, 2010

    Report

    Report Number
    3004209178-2010-06499
    Event Type
    Death
    Date Received
    August 26, 2010
    Date of Event
    April 5, 2010
    Report Date
    July 29, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD INCREASED PAIN. A REVISION OF THE CATHETER CONNECTOR TOOK PLACE ON (B)(6)2010. THE PT RECOVERED WITHOUT SEQUELA. IT WAS LATER REPORTED THE PUMP CONTAINED MORPHINE AT 20 MG/ML AT A DOSE OF 11.992 MG/DAY, BUPIVICAINE 27 MG/ML AT A DOSE OF 16.189 MG/DAY AND COMPOUNDED BACLOFEN 1050 UG/ML AT A DOSE OF 629.9 UG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention| D CATHETER: MODEL 8709, LOT # N092221021.| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT # N092221021| EXPLANTED:| IMPLANTED: