BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1181756 · Received September 30, 2008

    Report

    Report Number
    3004209178-2008-06222
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 4, 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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PUMP WAS LAST FILLED IN 2008 WITH 20 MLS OF FENTANYL. THE PATIENT EXPERIENCED UNSPECIFIED WITHDRAWAL SYMPTOMS. THE PUMP WAS FOUND TO HAVE MORE VOLUME THAN EXPECTED. THE EXPECTED RESERVOIR VOLUME WAS 15.7 MLS; THE ACTUAL VOLUME WAS 19.5 MLS. THE PATIENT HAD NOT HAD AN MRI OR OTHER EMI EXPOSURE. NO ALARMS WERE HEARD AND THERE WERE NO STALL OR ALARM MESSAGES WHEN THE PUMP WAS INTERROGATED. THE LOGS WERE CHECKED AND APPEARED NORMAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 56 YR Required Intervention PROGRAMMER: MODEL 8840| EXPLANTED:| PROGRAMMER: MODEL 8832| CATHETER: MODEL 8709