BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1972417 · Received January 24, 2011

    Report

    Report Number
    3004209178-2011-00562
    Event Type
    Injury
    Date Received
    January 24, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 14, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    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

    THREE MONTHS AGO, THE DISTAL CATHETER WAS REPLACED; THE REASON WAS NOT PROVIDED. FOLLOWING THE REPLACEMENT, THE PT NEVER HAD THERAPEUTIC EFFECT. THE PT'S DOSE WAS INCREASED FROM 100 MCG/DAY TO 600 MCG/DAY. THE PHYSICIAN WAS NOT SURE IF THE DOSE WAS HIGH ENOUGH BECAUSE THE PT WAS ON A HIGH DOSE PRIOR TO THE REVISION. AS A PRECAUTION, THEY PLANNED TO DO DIAGNOSTICS TO DETERMINE THAT THE SYSTEM WAS FUNCTIONING. IT WAS ALSO NOTED THAT THE PT HAD A SEROMA FOLLOWING THE CATHETER REVISION, BUT IT HAD SINCE HEALED. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL. ADD'L INFO HAS BEEN REQUESTED AND A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N146671006