BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2864252 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11378
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 25, 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
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THEY WERE UNABLE TO REFILL THE PUMP. THE PUMP WAS CONFIRMED TO BE FLIPPED. THE PUMP WAS SURGICALLY REVISED AND RE-ATTACHED. THE PATIENT OUTCOME WAS REPORTED AS "NO INJURY." THE DEVICE SYSTEM WAS DELIVERING LIORESAL.

    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 00054 YR Required Intervention