BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHROMED II

    MDR report key: 640030 · Received September 29, 2005

    Report

    Report Number
    2182207-2005-01533
    Event Type
    Other
    Date Received
    September 29, 2005
    Report Date
    September 23, 2005
    Manufacturer
    NEUROLOGICAL DIVISION, MEDTRONIC, INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PUMP WAS EXPLANTED AND RETURNED TO THE MFR FOR ANALYSIS. NO REASON FOR THE EXPLANT OR IMPLANT DURATION WAS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE HCP REPORTS THE PT DEVELOPED A HEMATOMA UNDER THE PUMP SITE. THE PT HAD SURGERY FOR AN INCISION AND DRAINAGE. THE WOUND WAS NON-HEALING AND THE CATHETER WAS EXPOSED. THE PUMP WAS REMOVED IN 08/2005. THE PUMP WAS REPLACED ON THE OPPOSITE SIDE IN 08/2005. THE PT RECOVERED WITHOUT SEQUELA AND IS DOING WELL NOW. THE OLD PUMP SITE HEALED AND THE PT IS EXPERIENCING ADEQUATE PAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP LKK NEUROLOGICAL DIVISION, MEDTRONIC, INC. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization