BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2250697 · Received September 12, 2011

    Report

    Report Number
    3004209178-2011-07718
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 6, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT EXPERIENCED WITHDRAWAL. THERE WAS A VOLUME DISCREPANCY; THE RESERVOIR WAS ACCESSED AND IT WAS NOTED THAT "THE SAME AMOUNT OF DUG IS STILL IN RESERVOIR". THE HCP PLANNED TO PERFORM A CATHETER DYE STUDY AND A (B)(6) STUDY. THE PUMP CONTAINED BACLOFEN. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CATHETER: MODEL 8709, LOT# J11495R18| IMPLANTED:| EXPLANTED: