BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3923723 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12767
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE ANCHOR SITE WAS BOTHERING THE PATIENT SO, THE ANCHOR WAS BURIED DEEPER. THE PUMP CONTAINED DILAUDID. IT WAS FURTHER REPORTED THE ISSUE WAS RESOLVED WHEN THEN ANCHOR WAS BURIED DEEPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401433 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention