BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1213812 · Received October 28, 2008

    Report

    Report Number
    2182207-2008-06935
    Event Type
    Injury
    Date Received
    October 28, 2008
    Report Date
    September 24, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE. THE PUMP 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 PT WAS NOT GETTING PAIN RELIEF FOR SOME TIME. THERE WAS A RECENT INCREASE IN RESIDUAL VOLUMES AT REFILLS; THE VOLUMES WERE NOT REPORTED. THE PUMP WAS REPLACED. THE PT RECOVERED WITHOUT SEQUELA. THERE WAS NO PT INJURY. THE PUMP WAS USED TO DELIVER DILAUDID (20 MG/ML) AT A RATE OF 11.5 MG/DAY. THE PUMP WAS ALSO USED TO DELIVER BUPIVACAINE; THE CONCENTRATION AND DOSE WERE NOT PROVIDED.

    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 86 YR Required Intervention CATHETER: MODEL 8711| PROGRAMMER: MODEL 8840| EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 8590-1| IMPLANTED:| IMPLANTED: