BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3150398 · Received June 6, 2013

    Report

    Report Number
    3007566237-2013-01879
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER ¿FAILED¿ AND HAD TO BE REPLACED. THE PATIENT INDICATED HE STARTED ¿GETTING WORSE INSTEAD OF BETTER¿ AND IT WAS DISCOVERED THE CATHETER HAD BROKEN, AS WAS ¿CLEARLY SHOWN¿ BY MRI. THE PATIENT WENT AHEAD WITH A CATHETER REVISION. DRUG DELIVERED VIA THE DEVICE WAS PRIALT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249887 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention