BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2913425 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-00514
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    October 6, 2016
    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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER MODEL # 8731SC, SERIAL # UNK. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE AND CONCLUSION CODES HAVE BEEN UPDATED; THE PREVIOUSLY SUBMITTED DEVICE AND CONCLUSION CODES NO LONGER APPLY.

    Description of Event or Problem · 1

    THE MAGNETIC RESONANCE IMAGE (MRI) DONE (B)(6) 2013 CONFIRMED ARACHNOIDITIS. THERE WAS SIEROMIELIA, ARACHNOID ITIS, AND TISSUE ADHERING TO THE CATHETER. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PLANNED. THE PHYSICIAN REFUSED TO PERFORM A REVISION DUE TO THE ARACHNOIDITIS. THE PATIENT STATUS WAS UNCHANGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED LOSS OF THERAPEUTIC EFFECT AND REQUIRED HOSPITALIZATION. THE PATIENT'S SPASTICITY RETURNED. THE EVENT/DIFFICULTY OCCURRED ON APPROXIMATELY (B)(6) 2012. A PHYSICIAN INCREASED THE LIORESAL DOSE UNTIL 700 MCG/DAY WAS REACHED; HOWEVER, NO IMPROVEMENT OCCURRED. THE VOLUME OF DRUG EXPECTED AT THE TIME OF A PUMP REFILL WAS NOTED AS BEING "OK." THE PHYSICIAN DECIDED TO PERFORM AN INDIUM DYE TEST. THE DYE TEST REVEALED A "STOP BEFORE ABOUT 10 CM FROM THE TIP OF THE CATHETER." THE PHYSICIAN SUSPECTED A DISCONNECTION BETWEEN THE CATHETER AND THE PUMP BECAUSE THE VOLUME EXPECTED WAS OK; OR A LOSS OF DRUG FROM THE RESERVOIR REFILL PORT BECAUSE HE REFILLED THE PUMP WITHOUT "NONCORING" NEEDLE. IT WAS NOTED THAT ACTIONS HAD NOT YET BEEN PROGRAMMED. A DEVICE REVISION PROCEDURE WAS NOTED AS BEING REQUIRED. AN MRI WAS SCHEDULED TO VERIFY ARACHNOIDITIS. THE NEUROSURGEON REFUSED TO DO SURGERY BECAUSE ARACHNOIDITIS WAS SUSPECTED. THE STATUS OF THE PATIENT WAS NOTED AS "ALIVE - WITH INJURY." THE PUMP WAS DELIVERING LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20306 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization