BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2113731 · Received June 2, 2011

    Report

    Report Number
    3007566237-2011-03919
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 2, 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE ISSUES WITH THE DRUG LEAVING THE PUMP. NO MOTOR STALL WAS NOTED IN THE LOGS. THE CATHETER HAD BEEN ASPIRATED AT THE TIME OF THIS PUMP IMPLANT. THE PHYSICIAN SUSPECTED THERE COULD HAVE BEEN AN OCCLUSION AT THE PUMP/CATHETER CONNECTION. THE PUMP WAS REPLACED. SEE MANUFACTURER REPORT 3004209178-2011-01855 FOR THE PREVIOUS PUMP REPLACEMENT. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS NOT KNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention LOT# NGP349084H| EXPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 8637-20| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N269933007| EXPLANTED:| IMPLANTED: