BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1162790 · Received September 16, 2008

    Report

    Report Number
    3004209178-2008-05776
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    July 1, 2008
    Report Date
    August 18, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PUMP CONNECTOR WAS REPLACED AND THE PUMP WAS FILLED WITH SALINE (SEE MANUFACTURER'S REPORT NUMBER 300420917200804223). AFTER APPROXIMATELY ONE WEEK, THE SALINE WAS REMOVED FROM THE PUMP AND THE PUMP WAS FILED WITH FENTANYL INSTEAD OF MORPHINE. AFTER 12 HOURS, THE PATIENT WAS FOUND IN A COMATOSE CONDITION BY HER DAUGHTER. THE PHYSICIAN STATED THAT THE PUMP HAD DELIVERED 1.7 MLS INSTEAD OF THE 0.4 MLS WHICH HE HAD PROGRAMMED; THIS ASSESSMENT WAS BASED ON THE DIFFERENCE BETWEEN THE ASPIRATED DRUG AND DECLARATION IN THE PROGRAMMER. THE PUMP WAS AGAIN FILLED WITH SALINE. THE PATIENT REMAINED HOSPITALIZED FOR SLOW TITRATION OF THE FENTANYL AND FOR TREATMENT OF OTHER UNSPECIFIED DISEASES.

    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 UNK Hospitalization| L| R PUMP CONNECTOR MODEL 8578 LOT# B0812556K IMPLANTED| EXPLANTED| PROGRAMMER MODEL 8840 SERIAL# UNK