BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1890211 · Received October 22, 2010

    Report

    Report Number
    3004209178-2010-08290
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 27, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITH INCREASED DOSAGE, THE PT DID NOT RECEIVE IMPROVED THERAPEUTIC EFFECT. IT WAS DETERMINED BY THE PT'S HEALTHCARE PROVIDER (HCP) THAT THE PT'S PUMP FAILED, "AS LATE AS LAST WEEK." THERE WAS NO INFO PROVIDED REGARDING THE CONCENTRATION OR DOSAGE OF LIORESAL USED IN THE PT'S PUMP. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFO WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT # N098119018