BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2050171 · Received April 1, 2011

    Report

    Report Number
    3004209178-2011-02484
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    January 1, 2009
    Report Date
    March 22, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SINCE THE PUMP WAS IMPLANTED, THE PT'S SPASTICITY HAS PROGRESSIVELY GOTTEN WORSE. THE PT'S STATUS WAS "FAIR." THE ACTUAL RESIDUAL PUMP VOLUME WAS GREATER THAN THE EXPECTED VOLUME; SPECIFIC VOLUME AMOUNTS WERE NOT KNOWN BY THE REPORTER. NO DIAGNOSTIC STUDIES WERE PERFORMED, ONLY THE PUMP DOSE HAS BEEN INCREASED. THE REPORTER WAS CONSIDERING HEALTHCARE PROVIDER OPTIONS. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N144088021