BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2031578 · Received March 25, 2011

    Report

    Report Number
    3007566237-2011-02126
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP AND CATHETER WERE RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THERE WERE PROBLEMS AFTER PUMP REFILL (NOT SPECIFIED). THE PT DECIDED TO HAVE THE DEVICE SYSTEM REMOVED. THE PT STATUS WAS REPORTED AS OK PRIOR TO EXPLANT. AT EXPLANT THE EXPECTED RESERVOIR VOLUME WAS 38 MLS; 25 MLS WERE REMOVED. NO ALARMS OR WARNINGS WERE DISPLAYED ON A PUMP LOG PRINTED ON THE DATE OF EXPLANT. THE PUMP WAS USED TO DELIVER MORPHINE, 20 MG/ML. THE PUMP HAD BEEN SET TO MINIMUM RATE. THE PT RECOVERED WITHOUT SEQUELA AFTER DEVICE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8709, LOT# J11955R11| EXPLANTED: