BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1074129 · Received June 20, 2008

    Report

    Report Number
    2182207-2008-03098
    Event Type
    Injury
    Date Received
    June 20, 2008
    Report Date
    January 18, 2005
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION WHICH COVERS A 3-YEAR RETROSPECTIVE REVIEW OF PREVIOUS CALLS THAT WERE NOT FORWARDED TO COMPLAINT HANDLING FROM PT/TECHNICAL SVCS FOR MDR REVIEW DURING THE TIME PERIOD OF 6/1/04 TO 5/1/07 (INCLUSIVE). THIS EXEMPTION WAS GRANTED TO SATISFY MEDTRONIC'S MDR OBLIGATIONS FOR ANY PREVIOUSLY UNREPORTED SERIOUS INJURY AND MALFUNCTION EVENTS FOUND DURING THIS REVIEW. THIS MEDWATCH REPORT REPRESENTS 1 UNREPORTED SERIOUS INJURY EVENT FOR MODEL 8731, 3 SERIOUS INJURY EVENTS FOR MODEL DDB CATHETER, 2 SERIOUS INJURY EVENTS FOR MODEL 8637, 1 SERIOUS INJURY EVENT FOR MODEL DDB PUMP, 1 SERIOUS INJURY EVENT FOR MODEL 8627L10, AND 1 SERIOUS INJURY EVENT FOR MODEL 8627-18 FOR THE ABOVE TIME PERIOD (ALL PRODUCT CODE LKK). THIS TOTAL INCLUDES THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT DEVELOPED A SEROMA THAT REQUIRED REVISION OF THE SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CATHETER MODEL CATHETER LOT# UNK IMPLANTED: | EXPLANTED:| EXPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT# UNK IMPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT# UNK IMPLANTED:| EXPLANTED:| EXPLANTED:| CATHETER MODEL CATHETER LOT# UNK IMPLANTED: