BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1171207 · Received September 22, 2008

    Report

    Report Number
    3004209178-2008-06010
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 25, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - USED FOR THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A CATHETER REVISION. NO REASON FOR THE REVISION WAS PROVIDED. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, 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 MEDTRONIC PUERTO RICO OPERATIONS CO. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL 8598 LOT# N001405751| IMPLANTED| PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTED| EXPLANTED| EXPLANTED| CATHETER MODEL 8703W LOT# L52353