BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2883600 · Received December 21, 2012

    Report

    Report Number
    3004209178-2012-12161
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    November 15, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S ENTIRE DEVICE SYSTEM WAS REPLACED. IT WAS REPORTED THAT THE PATIENT HAD NOT RECEIVED ADEQUATE THERAPY (LESS THAN 50% THERAPY RELIEF). IN ADDITION, HE HAD NOT RECEIVED ADEQUATE SPASTICITY RELIEF (GENERALIZED SPASTICITY) FROM THE SYSTEM SINCE IT WAS REVISED IN (B)(6) 2012. IT WAS INDICATED WHEN THE PHYSICIAN CUT THE CATHETER PROXIMAL V-WING ANCHOR, THERE WAS SPONTANEOUS CEREBRAL SPINAL FLUID (CSF) FLOW. THE PHYSICIAN SUSPECTED THAT POSSIBLY THE CATHETER WAS "SITTING IN THE ARACHNOID", "RESULTING IN POOR DRUG FLOW". THE ENTIRE CATHETER WAS REPLACED AND THERE WAS GOOD CSF FLOW. IT WAS NOTED AT THE TIME OF THIS REPORT THAT THE PATIENT WAS ALIVE AND WITHOUT INJURY. THE DRUG DELIVERED VIA PUMP WAS LIORESAL.

    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