BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1971613 · Received January 25, 2011

    Report

    Report Number
    3004209178-2011-00582
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    February 2, 2010
    Report Date
    December 31, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT EXPERIENCED INCREASED PAIN ASSOCIATED WITH THE PREVIOUSLY REPORTED EVENT. IT WAS FOUND THAT THE CATHETER WAS KINKED DUE TO SCAR TISSUE. A CATHETER ACCESS PORT (CAP) CONTRAST STUDY PERFORMED ON (B)(6) 2010, FOUND THE PRESENCE OF A POSSIBLE LEAK AT THE PUMP POCKET SITE.

    Description of Event or Problem · 1

    A CATHETER DYE STUDY WAS DONE; THE CATHETER "FAILED" THE DYE STUDY. THE CATHETER WAS REVISED ON (B)(6) 2010. THE PT HAD NO SYMPTOMS AND RECOVERED WITHOUT SEQUELA. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT#N126737003