BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 3041231 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01743
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    May 7, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LABORATORY ANALYSIS CONCLUDED THIS DEVICE MET SPECIFICATION FOR LONGEVITY WITH NO BATTERY ANOMALIES IDENTIFIED.

    Additional Manufacturer Narrative · 1

    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

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT RECENTLY UNDERWENT A PROCEDURE TO REPLACE THE PULSE GENERATOR, HOWEVER, PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE INFECTION WAS NOTED TO HAVE FULLY CLEARED AND THE LEADS REMAIN IMPLANTED WITH THE NEW DEVICE. THE DEVICE WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO POCKET VOLUME INCREASE DUE TO A SUSPECTED INFECTION. THE PATIENT REMAINS IN THE HOSPITAL UNDER ANTIBIOTHERPAY MEDICATION. AS THE PULSE GENERATOR IS AT ELECTIVE REPLACEMENT INDICATOR (ERI), A REPLACEMENT PROCEDURE WILL LIKELY TAKE PLACE IN THE NEAR FUTURE, IN WHICH THE ENTIRE SYSTEM WILL LIKELY BE EXPLANTED. HOWEVER, AT THIS TIME THE PRODUCT REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143568 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H197

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R