BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 855552 · Received May 24, 2007

    Report

    Report Number
    3004209178-2007-01783
    Event Type
    Injury
    Date Received
    May 24, 2007
    Report Date
    April 24, 2007
    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
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MFR REP REPORTED THE DEVICE SYSTEM WAS REMOVED DUE TO INFECTION. ADD'L INFO HAS BEEN REQUESTED BY MEDTRONIC FROM THE HEALTH CARE PROFESSIONAL REGARDING THE REPORTED EVENT. A SUPPLEMENTAL MDR F/U REPORT WILL BE SENT TO FDA IF ADD'L INFO IS REC'D.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention CATHETER MODEL 8711 LOT# N086467005| PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED| EXPLANTED