BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2031488 · Received March 25, 2011

    Report

    Report Number
    3007566237-2011-02113
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP WAS 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 EXPERIENCED DECREASED DRUG EFFECT. THE PUMP WAS ALARMING. A MOTOR STALL HAD OCCURRED. THE STALL HAD NOT BEEN PRECEDED BY A SCAN OR X-RAY. IT WAS REPLACED. THE PUMP WAS USED TO DELIVER MORPHINE AND CLONIDINE. 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 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention CATHETER: MODEL 8709, LOT# J12428R18| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J12428R18