BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2173861 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-11329
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 21, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RECORDS INDICATE THIS DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRESENTED TO THEIR CLINIC AND EXPERIENCED SYNCOPE. THE PATIENT WAS THEN ADMITTED TO THE HOSPITAL FOR APPROXIMATELY A WEEK. IT WAS REPORTED THAT THE DEVICE OUTPUTS REQUIRED REPROGRAMMING. A DEVICE REPLACEMENT PROCEDURE WAS PLANNED FOR A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H219

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization MISMATCH| H219| 4518| 1581| (B)(4)