BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1243713 · Received November 25, 2008

    Report

    Report Number
    2182207-2008-07746
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    September 17, 2008
    Report Date
    October 30, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USED FOR THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A MASS AT T9-T12 NOTED ON MRI IN 2007. THE PATIENT UNDERWENT A CATHETER REVISION IN 2008. A CT MYELOGRAM REVEALED AN INTRADURAL CYST T7-T11 (DATE NOT REPORTED). SURGICAL DECOMPRESSION OF THE INTRADURAL CYST WAS PERFORMED ON TWO MONTHS LATER. THE PATIENT UNDERWENT NEUROSURGERY FOR UNSPECIFIED REASONS IN THE FOLLOWING MONTH. NO PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IT WAS UNKNOWN WHAT DRUGS WERE IN THE PUMP AT THE TIME OF THESE EVENTS. THE PUMP WAS SUBSEQUENTLY REPLACED ON APPROX FIVE MONTHS LATER. REFER TO MANUFACTURER'S REPORT #: 2182207200806313.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8711| IMPLANTED:| PROGRAMMER: MODEL 8840