BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1913974 · Received November 30, 2010

    Report

    Report Number
    3004209178-2010-10028
    Event Type
    Injury
    Date Received
    November 30, 2010
    Report Date
    November 19, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SINCE THE IMPLANT SURGERY, THE PT EXPERIENCED REDNESS AND ITCHINESS AT THE PUMP INCISION SITE. THERE WAS NO ODOR AT THE SITE. THE PT WAS TAKING ANTIBIOTICS. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT# J11404R53