BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3800734 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08755
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 16, 2014
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A CATHETER BREAK ON THE PROXIMAL SEGMENT. THE EVENT REQUIRED REVISION ON (B)(6) 2014. THERE WAS A PARTIAL EXPLANT IN WHICH THE FRACTURED SECTION OF THE CATHETER WAS TRIMMED AND REPLACED. THE SYSTEM WAS REPROGRAMMED. A DYE STUDY WAS PERFORMED. THE PRODUCT ISSUE WAS RESOLVED, BUT THE CAUSE WAS NOT DETERMINED. THE EVENT OCCURRED DURING NORMAL USE. IT WAS REPORTED THE PUMP WAS BEING USED TO DELIVER HYDROMORPHONE, CLONIDINE, AND BUPIVACAINE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT AND THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ¿ALIVE- NO INJURY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278361 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention