BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2914253 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-00561
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), LOT # N359827, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING IMPLANT, THE SURGEON WAS PLACING THE CATHETER ONTO THE CONNECTOR AND THE COLLET DEPLOYED BEFORE THE CATHETER WAS SECURELY ON THE COLLET. A REVISION KIT WAS NEEDED FOR A NEW COLLET; SURGERY TIME WAS PROLONGED. THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20812 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Other