BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2073587 · Received April 27, 2011

    Report

    Report Number
    3004209178-2011-03133
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 12, 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
    KY, 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

    IT WAS REPORTED THAT THE PT EXPERIENCED WITHDRAWAL SYMPTOMS OF INCREASED PAIN AND NAUSEA IN (B)(6) 2011. A VOLUME DISCREPANCY WAS NOTED ON (B)(6) 2011 WITH AN EXPECTED RESIDUAL VOLUME OF 1.2 ML AND ACTUAL RESIDUAL VOLUME OF 5.4 ML. THE PT'S PUMP WAS REPLACED. THE PT RECOVERED WITHOUT SEQUELA. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE BUPIVACAINE, CLONIDINE, AND DILAUDID.

    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 59 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8711, LOT # L78727| EXPLANTED: