BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2592722 · Received May 30, 2012

    Report

    Report Number
    3004209178-2012-03839
    Event Type
    Injury
    Date Received
    May 30, 2012
    Report Date
    May 3, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED, PRODUCT TYPE: CATHETER; PRODUCT ID 8578, LOT# N153694, SERIAL#, IMPLANTED: 2009 (B)(6), EXPLANTED, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID, PRIALT, AND BUPIVACAINE. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF LESS PAIN RELIEF. IT WAS DIFFICULT TO DIFFERENTIATE FROM THE PATIENT'S REFLEX SYMPATHETIC DYSTROPHY (RSD) EXACERBATIONS, BUT NO SPECIFIC REPORTS OF WITHDRAWAL WERE MADE. A SIDE PORT DYE STUDY WAS PERFORMED AND WAS UNSUCCESSFUL. THE PHYSICIAN WAS UNABLE TO ASPIRATE FROM THE SIDE PORT OF THE PUMP. IT WAS LATER REPORTED THAT A NEW CATHETER AND PUMP WERE IMPLANTED ON (B)(6) 2012. THE OLD CATHETER WAS NOT EXPLORED EXCEPT AT THE PUMP POCKET SITE TO VERIFY THE INABILITY TO ASPIRATE. THE OLD CATHETER WAS LEFT IN PLACE AND TIED OFF. ONE WEEK POST-OPERATIVE, THE PATIENT WAS GETTING GOOD RELIEF AT SIGNIFICANTLY LOWER DOSES. 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 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention