BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1668751 · Received April 14, 2010

    Report

    Report Number
    3007566237-2010-03002
    Event Type
    Death
    Date Received
    April 14, 2010
    Date of Event
    February 3, 2010
    Report Date
    March 22, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THEY WERE UNABLE TO FIND OUT THE CIRCUMSTANCES SURROUNDING THE PATIENT'S DEATH. THE PATIENT WAS LAST SEEN BY THEIR MANAGEMENT PHYSICIAN ON (B) (6) 2009. AN MRI OF THE PATIENT'S BRAIN WAS PERFORMED ON (B) (6) 2009. THE MRI SHOWED ISCHEMIC DISEASE. THE PATIENT HAD DIFFICULTY WALKING AND HAD QUADRIPARESIS. THEY STATED THAT THEY DID NOT THINK THAT THE PATIENT'S DEATH WAS RELATED TO THE IMPLANTED DEVICE SYSTEM. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE BUPIVICAINE AND FENTANYL.

    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 65 YR Death IMPLANTED:| CATHETER: MODEL 8709, LOT# J0056597R| PROGRAMMER: MODEL 8840, LOT# UNKNOWN| EXPLANTED: