BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1022581 · Received April 1, 2008

    Report

    Report Number
    3004209178-2008-01726
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 3, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED DUE TO INFECTION. NO PATIENT SYMPTOMS OR OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER MODEL 8709SC LOT# N132980035| PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED:| IMPLANTED:| CATHETER MODEL 8596SC LOT# N136380007