BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1823451 · Received August 25, 2010

    Report

    Report Number
    3004209178-2010-06446
    Event Type
    Injury
    Date Received
    August 25, 2010
    Report Date
    July 28, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE PT DEVELOPED AN INFECTION WHICH CAUSED A SUBCUTANEOUS POCKET PROBLEM. THE INFECTION WAS NOTICED DURING A REFILL. THE PT SUFFERS FROM DYSTONIA AND LATEROFLECTION WHICH CAUSES BEDSORE-LIKE SYMPTOMS AT THE IMPLANT SITE. THE PUMP AND CATHETER WERE GOING TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8711, LOT # N188229009