BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2172584 · Received July 20, 2011

    Report

    Report Number
    3004209178-2011-05610
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS IMPLANTED ON (B)(6) 2011. THE PT DEVELOPED AN INFECTION OF THE PUMP POCKET; THE BACTERIA WAS UNK. THE PT WAS HOSPITALIZED. THE PT HAD NO FEVER AND NO DISCOMFORT. THE PUMP WAS EXPLANTED ON (B)(6) 2011. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R