BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1190707 · Received October 6, 2008

    Report

    Report Number
    2182207-2008-06342
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 10, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD AN MRI AND WAS CURRENTLY IN THE EMERGENCY ROOM. THE HCP INDICATED "POSSIBLE PUMP CONCERNS." NO SPECIFIC SYMPTOMS WERE REPORTED. THE PUMP CONTAINED BACLOFEN AND DILAUDID. IT WAS SUBSEQUENTLY REPORTED THAT THE PT WAS DISCHARGED. NO OTHER INFO WAS PROVIDED AT THE TIME OF THIS REPORT. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention PROGRAMMER: MODEL 8840| CATHETER: MODEL 8731SC| EXPLANTED: