BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1151303 · Received September 4, 2008

    Report

    Report Number
    3004209178-2008-05455
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 6, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: USED FOR THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS REMOVED AND WAS "ENCRUSTED WITH INFECTION". PER THE REPORTER, THE INFECTION WAS DIAGNOSED A WEEK AGO. THE PT REMAINED HOSPITALIZED FOR OTHER REPORTED MEDICAL ISSUES. PLEASE REFER TO MANUFACTURER'S REPORT #: 300420917800805413 FOR ADDITIONAL INFO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R CATHETER MODEL 8709SC LOT# N135405011| EXPLANTED| IMPLANTED| IMPLANTED| EXPLANTED| PROGRAMMER MODEL 8832 LOT# NJG005484N