BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1651577 · Received April 2, 2010

    Report

    Report Number
    3004209178-2010-02704
    Event Type
    Death
    Date Received
    April 2, 2010
    Date of Event
    March 4, 2010
    Report Date
    March 9, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    THE PT WAS RECENTLY DIAGNOSED AS HAVING A CEREBELLAR TUMOR. THE IMPLANTED PUMP WAS REFILLED ON (B) (6) 2010. THE PT WAS PREPARING FOR GAMMA-KNIFE SURGERY. SHE DIED ON (B) (6) 2010. THE DEATH WAS NOT ATTRIBUTED TO THE PUMP SYSTEM. THE CAUSE OF DEATH WAS NOT KNOWN BY THE REPORTING HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N133638002| PROGRAMMER: MODEL 8840, LOT# UNK