BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1253159 · Received December 5, 2008

    Report

    Report Number
    3004209178-2008-08031
    Event Type
    Injury
    Date Received
    December 5, 2008
    Report Date
    November 12, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS REDNESS AROUND THE PUMP POCKET SITE. NO OTHER PT SYMPTOMS WERE REPORTED. THE PT WAS ON ANTIBIOTICS. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL 8709SC| IMPLANTED:| ACCESSORY MODEL 8590-1| IMPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER MODEL 8840