BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1924800 · Received December 7, 2010

    Report

    Report Number
    3004209178-2010-10256
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 29, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P8600004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP 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

    THE PT EXPERIENCED INCREASED PAIN AND SYMPTOMS OF WITHDRAWAL. THE PUMP HAD A MOTOR STALL. THE PUMP WAS REPLACED. THERE WAS REPORTED TO BE NO PT INJURY. THE PT RECOVERED WITHOUT SEQUELA. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED; THE NEW PUMP WAS FILLED WITH MORPHINE, FENTANYL, AND BUPIVACAINE.

    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 53 YR Required Intervention CATHETER: MODEL 8711, LOT# N123630004| IMPLANTED:| EXPLANTED: