BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2220216 · Received August 16, 2011

    Report

    Report Number
    3004209178-2011-06399
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 21, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    A CATHETER BREAK WAS CONFIRMED ON (B)(6) 2011 AND THE PUMP WAS REPLACED. THE DRUG DELIVERED WAS GABALON (BACLOFEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention| H CATHETER: MODEL 8711, LOT# N160635021| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT# N160635021| EXPLANTED: