BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 3211667 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09106
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 10, 2013
    Report Date
    June 21, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE HOSPITAL DISCARDED THE DEVICE AND THE RETURN IS NOT EXPECTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE DID NOT EMIT TONES WITH MAGNET PLACEMENT. AN INVASIVE PROCEDURE WAS PERFORMED. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS UNABLE TO BE INTERROGATED WITH A PROGRAMMER. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED PLACING A MAGNET OVER THE DEVICE TO ATTEMPT TO ELICIT TONES OR PERFORMING AN X-RAY TO VERIFY THE DEVICE ID. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309074 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H179

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R 0157| 5076| 1853| N164| H179| 4512