BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3023065 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-04289
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 2, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE INFUSION PUMP REVEALED THE FOLLOWING: THERE WAS A GEAR TRAIN ANOMALY FOUND AND INDICATED AS CORROSION.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL AFTER HEARING AN ALARM FROM THE PUMP. UPON INTERROGATION, IT WAS SEEN THAT THE MOTOR HAD STALLED AND COULDN'T BE RESTARTED. THE PATIENT WAS HOSPITALIZED AND A PUMP EXPLANT WAS PLANNED. TEN DAYS LATER, IT WAS REPORTED THAT PATIENT HAD EXPERIENCED WITHDRAWAL SYMPTOMS ON THE PRIOR FRIDAY NIGHT. THE ALARM SOUNDED ABOUT TWO HOURS LATER. TEN DAYS AFTER THAT, IT WAS REPORTED THAT THE PATIENT FELT FINE AND WAS RECEIVING EFFECTIVE THERAPY FOLLOWING THE PUMP REPLACEMENT PROCEDURE. THE DRUGS USED IN THIS SYSTEM WERE LIORESAL AND DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126757 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R