BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL 3 RF

    MDR report key: 1041824 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34815
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 26, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    Z-0863-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL 3 RF IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H215 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention THE DEVICE 6482 030353 WAS USED DURING THE EVENT.| THE DEVICE 4525/161085 WAS IMPLANTED 11-MAR-2008| THE DEVICE 4135/282754 WAS IMPLANTED 11-MAR-2008| THE DEVICE 6947/TDG045 WAS IMPLANTED 26-JUN-2003