BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2032504 · Received March 24, 2011

    Report

    Report Number
    3004209178-2011-02260
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 4, 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
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT WAS AT HOME AND HEARD THE PUMP ALARMING AT 18:03. THE PUMP WAS INTERROGATED THE NEXT DAY AND A MOTOR STALL WITH NO RECOVERY WAS CONFIRMED VIA THE TELEMETRY. THE PUMP WAS REPLACED. THERE WAS REPORTED TO BE NO PT INJURY AND THE PT RECOVERED WITHOUT SEQUELA. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID AND CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8709, LOT # L73609| EXPLANTED: