BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2963887 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02716
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER: PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER: PRODUCT ID 8590-9, LOT# N331028, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ASPIRATION PNEUMONIA AFTER HER IMPLANT SURGERY AND THE PATIENT STATED THAT SHE WAS "IN THE HOSPITAL FOR ANOTHER WEEK." THE MEDICATIONS USED WITHIN THE SYSTEM WERE BUPIVACAINE AND SUFENTA. THE PATIENT'S STATUS WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67214 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O