BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1469470 · Received September 1, 2009

    Report

    Report Number
    3004209178-2009-06095
    Event Type
    Injury
    Date Received
    September 1, 2009
    Date of Event
    June 16, 2009
    Report Date
    August 5, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    Description of Event or Problem · 1

    THE PT RETURNED FOR A PUMP REFILL AFTER HAVING BEEN FILLED. THE EXPECTED VOLUME WAS 8.2 ML; THE ACTUAL VOLUME WAS <1ML. THE CONCENTRATION AND DOSE OF THE DILAUDID AND BUPIVACAINE WAS DECREASED. THE PT EXPERIENCED A LOSS OF PAIN CONTROL. THE PT WAS SEEN AGAIN AT THE END OF THE MONTH, BECAUSE OF THE CONTINUED LOSS OF PAIN CONTROL. THE EXPECTED VOLUME WAS 14.8 ML; THE ACTUAL VOLUME WAS 0 ML. THE PUMP WAS FILLED WITH SALINE AND THE PT WAS SCHEDULED FOR SURGERY. SURGERY REVEALED NO FINDINGS EXCEPT THE PUMP EXPECTED VOLUME WAS 18.5ML AND THE ACTUAL VOLUME WAS 13.8ML. THE CATHETER WAS ASPIRATED WITHOUT DIFFICULTY. A CATHETER DYE STUDY WAS DONE AND REVEALED THAT THE CATHETER WAS PATENT. THE PUMP WAS REPLACED. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8703W| PROGRAMMER: MODEL 8840