BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3031140 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04486
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    January 31, 2013
    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
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8590-1, LOT# N160879, IMPLANTED: 2009-(B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), PRODUCT TYPE CATHETER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER MIGRATED/DISLODGED AT THE DISTAL SEGMENT. IT WAS NOTED THAT THE PATIENT STARTED GETTING A LOT OF PAIN AT THE END OF NOVEMBER, AND THE PHYSICIAN HAD INCREASED HER DOSE, BUT SHE HAD NO RELIEF. THE PATIENT EXPERIENCED PAIN, STATING SHE WAS NOT GETTING PAIN RELIEF FROM THE MEDICINE AND HER BACK STARTED HURTING HER. IT WAS NOTED THAT THE PATIENT THEN HAD COMPUTED TOMOGRAPHY (CT) SCAN 'SOMETIME IN (B)(6)', AND THE PATIENT WAS TOLD THAT THE CATHETER DISLODGED FROM THE INTRATHECAL SPACE AND WAS COILED. IT WAS ALSO NOTED THAT CEREBROSPINAL FLUID (CSF) WAS IN HER SUBCUTANEOUS TISSUES. THE PATIENT WAS THEN SCHEDULED FOR SURGICAL CATHETER REVISION. THE SURGEON DECREASED THE PATIENT'S DOSE BY 50% BEFORE THE SURGERY. DURING THE REVISION, THEY CUT PART OF THE ORIGINALLY IMPLANTED CATHETER AND ADDED A SPINAL SEGMENT FROM A REVISION KIT. THE PUMP SYSTEM WAS BEING USED TO DELIVER INFUMORPH AND BUPIVACAINE AT THAT TIME. IT WAS ADDITIONALLY REPORTED THAT FOLLOWING THE CATHETER REVISION, THE PATIENT WAS LETHARGIC, NAUSEOUS, HAD NOT BEEN ABLE TO EAT, AND HAD BEEN VOMITING. THE PHYSICIAN WAS RULING OUT SOME SURGICAL ISSUES, BUT ALSO WANTED THE PUMP STOPPED TO ELIMINATE THAT AS AN OPTION. THERE WAS CONCERN THAT THE PATIENT WAS 'KIND OF OVERDOSED'. THE PATIENT WAS IN THE HOSPITAL. IT WAS NOTED THE PUMP WAS DELIVERING MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134308 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Hospitalization| R