BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4255865 · Received November 17, 2014

    Report

    Report Number
    3004209178-2014-21707
    Event Type
    Injury
    Date Received
    November 17, 2014
    Date of Event
    October 21, 2014
    Report Date
    November 24, 2014
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709000002, SERIAL # (B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AT THE REFILL ON THE DATE OF THIS REPORT, THERE WAS A VOLUME DISCREPANCY. THE EXPECTED RESERVOIR VOLUME (ERV) WAS 9.1 CC AND THE ACTUAL RESERVOIR VOLUME (ARV) WAS 7.6 CC. THE PUMP HAD BEEN FILLED WITH 10 ML OF MEDICATION PREVIOUSLY. THE PUMP HAD A SEPARATE VOLUME DISCREPANCY AT THE PREVIOUS WEEKS REFILL AS WELL. THE ARV WAS 0CC AND THE ERV WAS 5.3CC. THE PUMP HAD BEEN FILLED WITH 20 CC PRIOR TO THAT REFILL. THE PATIENT WAS ASYMPTOMATIC. THE PATIENT WAS SCHEDULE FOR REPLACEMENT SURGERY FOR (B)(6) 2014. THE PUMP WAS USED TO DELIVER HYDROMORPHONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PUMP WAS EXPLANTED. THE PATIENT WAS DOING FINE AND SEEMED TO BE RECEIVING EFFECTIVE THERAPY. THE PUMP WAS SENT TO PATHOLOGY AND WAS DESTROYED AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743338 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention