BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3252254 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12418
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED CATHETER NOTED ONE END OF THE ANCHOR HAD FOLDED OVER ONTO ITSELF. THE CATHETER ANCHOR HAD NOT PROPERLY DETACHED FROM THE ASCENDA TOOL AND WAS NOT ABLE TO BE USED.

    Description of Event or Problem · 1

    A REPRESENTATIVE REPORTED THAT WHEN DEPLOYING THE ANCHOR FROM THE DEPLOYMENT TOOL, THE DISTAL END OF THE ANCHOR INVERTED UPON ITSELF, REQUIRING THE DEPLOYED ANCHOR TO BE CUT OFF AND ANOTHER ANCHOR TO BE USED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE MEDICATION USED WITHIN THE SYSTEM WAS GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352234 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR