BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2821607 · Received November 6, 2012

    Report

    Report Number
    3007566237-2012-02634
    Event Type
    Injury
    Date Received
    November 6, 2012
    Report Date
    October 9, 2012
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8711, LOT# L78413, IMPLANTED: (B)(6) 2000, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP AND CATHETER WERE REPLACED. THE CONCENTRATION AND DOSAGE OF FENTANYL WERE UNKNOWN. THE PATIENT OUTCOME WAS REPORTED AS HAVING NO PROBLEMS AFTER SURGERY AND WAS TITRATED BACK UP TO A THERAPEUTIC DOSAGE LEVEL BY HER MANAGING PHYSICIAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS DISLODGED. THE CATHETER PULLED OUT OF THE INTRATHECAL SPACE. IT WAS CONFIRMED VIA DYE STUDY. A PUMP REPLACEMENT AND CATHETER REVISION/REPLACEMENT WERE SCHEDULED BUT THEN CANCELLED DUE TO HIGH BLOOD SUGAR LEVEL. IT WAS THEN RESCHEDULED FOR (B)(6) 2012. THE PUMP WAS DELIVERING FENTANYL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention