BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2162078 · Received July 12, 2011

    Report

    Report Number
    3004209178-2011-05350
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 20, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFECTION WAS REPORTED BY THE HCP WITH SYMPTOMS OF FEVER AND REDNESS. PERI-OPERATIVE ANTIBIOTICS WERE GIVEN TO THE PT. TYPE, PRIMARY LOCATION OF THE INFECTION, LAB TESTS PERFORMED, PT OUTCOME WERE UNK. THE DRUG INFUSED VIA THE PUMP WAS COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N248128002