BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2190721 · Received July 26, 2011

    Report

    Report Number
    3004209178-2011-05787
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    May 11, 2011
    Report Date
    July 6, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z# 2380-2008
    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 INITIALLY REPORTED THAT THE PT WAS NOT GETTING PAIN RELIEF SINCE IMPLANT, AND THERE WAS A VOLUME DISCREPANCY WITH THE PUMP. THE ACTUAL RESIDUAL VOLUME WAS GREATER THAN EXPECTED, RESIDUAL VOLUME WAS FULL UPON ASPIRATION. THE SUTURELESS CONNECTOR (SC) WAS "CLOGGED" AND REVISED. IT WAS LATER REPORTED THAT A REFILL WAS ATTEMPTED ON (B)(6) 2011 BUT THE ENTIRE DRUG WAS ASPIRATED BACK. ON (B)(6) 2011 IN THE OPERATING ROOM, THE PHYSICIAN WAS UNABLE TO ASPIRATE CATHETER THROUGH THE CATHETER ACCESS PORT (CAP). ON DISCONNECTING THE SC, THE CATHETER HAD FREE FLOW OF CEREBROSPINAL FLUID (CSF), INDICATION THE CATHETER WAS PATENT. THE PHYSICIAN RE-ATTEMPTED TO ASPIRATE SC AND ATTEMPTED FLUSHING SC, BUT WAS UNABLE TO DO SO. THE SC WAS REMOVED AND REPLACED WITH NEW 8578. THE SYS WAS CONNECTED AND THE PHYSICIAN WAS ABLE TO ASPIRATE AND BOLUS THROUGH THE CATHETER WITHOUT DIFFICULTY. PT RECOVERED WITHOUT SEQUELA. THE DRUG INFUSED VIA THE PUMP WAS MORPHINE, COMPOUNDED 2 MG/ML, 0.4 MG/DAY.

    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 48 YR Required Intervention CATHETER: MODEL 8709SC, LOT # N281303003| IMPLANTED:| ACCESSORY: MODEL 8590-1, LOT # N281389| PROGRAMMER: MODEL 8835, LOT# NPG023259N| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED: