BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1120545 · Received August 15, 2008

    Report

    Report Number
    3004209178-2008-04989
    Event Type
    Death
    Date Received
    August 15, 2008
    Date of Event
    June 6, 2008
    Report Date
    July 21, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PATIENT'S DEVICE WAS RETURNED WITH NO INFO. ACCORDING TO THE MANUFACTURER'S DEVICE TRACKING SYSTEM, THE PT HAD EXPIRED. A FOLLOW-UP CALL WAS MADE TO THE MANAGING PHYSICIAN. THEY INDICATED THAT THE PT HAD METASTATIC PANCREATIC CANCER. THEY DID NOT HAVE ANY INFO REGARDING THE EXACT CAUSE OF DEATH AS THE PT HAD NOT BEEN SEEN SINCE 2008 WHEN SHE HAD A PUMP REFILL. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTED:| CATHETER MODEL 8709 LOT# N087346029| EXPLANTED: