BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1658014 · Received April 9, 2010

    Report

    Report Number
    3007566237-2010-02890
    Event Type
    Death
    Date Received
    April 9, 2010
    Date of Event
    October 1, 2006
    Report Date
    March 16, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPIRED THREE TO FOUR DAYS AFTER PUMP WAS IMPLANTED. THE CAUSE OF DEATH WAS UNK. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death CATHETER: MODEL 8709, LOT# L82125| PROGRAMMER: MODEL 8840, LOT# UNK| IMPLANTED:| EXPLANTED: