BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2802930 · Received October 24, 2012

    Report

    Report Number
    3007566237-2012-02502
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Report Date
    September 25, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT WAS ATTRIBUTED TO THE PUMP. THERE WOULD ALWAYS BE 2 TO 3 ML LEFT IN PUMP THAN WHAT IT SHOULD BE. IT WAS UNKNOWN IF THE EVENT WAS DUE TO CATHETER. THE ISSUE HAD BEEN RESOLVED. THE DEVICE WAS USED TO DELIVER COMPOUNDED BACLOFEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VOLUME DISCREPANCY WAS OBSERVED. THE ACTUAL RESIDUAL VOLUME (ARV) WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME (ERV). NO SPECIFIC VALUES WERE PROVIDED. THE PATIENT EXPERIENCED RETURN OF SYMPTOMS AND INCREASED SPASTICITY DESCRIBED AS 'STIFFER AND STIFFER'. NO AUDIBLE ALARMS WERE HEARD AND NO DIAGNOSTIC TESTS HAD BEEN PERFORMED AS OF THE DATE OF THE REPORT. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL (BACLOFEN). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME 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 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1