BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1865238 · Received October 6, 2010

    Report

    Report Number
    3004209178-2010-07669
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 11, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CATHETER HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PROBLEM WITH A CATHETER. THE HEALTH CARE PROFESSIONAL DISCOVERED "MICROTEARS" ON THE CATHETER DURING AN IMPLANT. THE MICROTEARS WERE DISCOVERED PRIOR TO THE HCP USING "PICK-UPS" ON THE CATHETER. THE PORTION OF THE CATHETER WITH THE MICROTEARS WAS SPLICED AND THE REMAINING LENGTH WAS IMPLANTED. THE PT WAS NOT INJURED AND RECOVERED WITHOUT SEQUELA. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS MORPHINE. A F/U 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 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT # UNK