BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1665660 · Received April 21, 2010

    Report

    Report Number
    3007566237-2010-03220
    Event Type
    Death
    Date Received
    April 21, 2010
    Date of Event
    October 1, 2009
    Report Date
    March 24, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004/S56
    Adverse Event
    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

    THE PT EXPIRED WHILE IN A NURSING HOME. IT WAS STATED THAT IT WAS NOT DEVICE RELATED. THE CAUSE OF DEATH WAS NOT PROVIDED.

    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 51 YR Death CATHETER: MODEL 8709, LOT# J0056634R| EXPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNK| IMPLANTED: