BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1840857 · Received September 16, 2010

    Report

    Report Number
    3007566237-2010-07025
    Event Type
    Death
    Date Received
    September 16, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 17, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED AT HOME, FOLLOWING A CATHETER REVISION SURGERY. THE SURGERY WAS PERFORMED ON (B)(6)2010, AND THE PATIENT WAS SENT HOME. THE DOSAGE OF DILAUDID (CONCENTRATION OF 30 MG/ML) IN THE PATIENT'S PUMP WAS "CUT IN HALF" (FROM 7.0 MG/DAY TO 3.5 MG/DAY) BY THE PATIENT'S PHYSICIAN, FOLLOWING THE SURGERY. THE CAUSE OF THE PATIENT'S DEATH WAS NOT KNOWN AT THE TIME OF THIS REPORT. IT WAS NOT KNOWN IF THE PATIENT'S DEATH WAS DEVICE RELATED. THE EXACT DATE OF DEATH WAS NOT KNOWN: IT OCCURRED "OVER NIGHT," ON EITHER (B)(6)2010 OR (B)(6)2010. NO FURTHER DETAILS OR PATIENT SYMPTOMS WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death CATHETER: MODEL 8709SC, LOT# N214092004| EXPLANTED:| IMPLANTED: