BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2844585 · Received November 26, 2012

    Report

    Report Number
    3004209178-2012-10730
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Report Date
    October 31, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATHETER: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012. (B)(4). ANALYSIS OF THE CATHETER SC CONNECTOR REVEALED DIFFICULTY WITH SC CONNECTOR LED TO EXPLANT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE METAL INNER COMPONENT ON THE PUMP CONNECTOR CAME OUT DURING A REVISION WHEN THE HCP REMOVED IT TO TRY AND ASPIRATE THE CATHETER. THE CONNECTOR WAS REMOVED AND A NEW PUMP CONNECTOR USED. THE CATHETER WAS REMOVED DUE TO A BREAK. THERE WERE NO PATIENT SYMPTOMS OR INJURIES REPORTED RELATED TO THE EVENT. THE PATIENT RECOVERED WITHOUT SEQUELAE. THE PUMP WAS USED TO DELIVER INFUMORPH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR