BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2924947 · Received January 22, 2013

    Report

    Report Number
    2124215-2013-01580
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    October 17, 2012
    Report Date
    January 29, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS PERFORMED ON THE DEVICE. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, TECHNICIANS USED AN ENGINEERING-LEVEL LONGEVITY PREDICTION CALCULATION TO ASSESS THE RATE OF BATTERY DEPLETION, GIVEN THE PROGRAMMED PARAMETERS AND OTHER DATA STORED WITHIN THE MEMORY OF THE DEVICE. THE RESULTS OF THIS CALCULATION INDICATED THAT THE ACTUAL RATE OF BATTERY DEPLETION FELL WITHIN AN ACCEPTABLE RANGE. NEXT, A COMPREHENSIVE SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED THAT VERIFIED THE PERFORMANCE OF THERAPY DELIVERY, SENSING, AND RECORDING FUNCTIONS. HAVING MET THE ENGINEERING LONGEVITY PREDICTION, FUNCTIONALLY PASSING ALL RETURNED PRODUCT TESTING, AND WITH NO FURTHER INFORMATION TO INDICATE A PRODUCT PERFORMANCE ISSUE, WE HAVE CONCLUDED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION.

    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

    SUBSEQUENTLY, UPON FURTHER REVIEW OF INFORMATION WAS REVIEWED. THE PATIENT HAD BEEN ADMITTED TO HOSPICE AND DID EXPIRE TEN MONTHS LATER FOLLOWING THE NORMAL DEVICE CHANGE. THERE WAS NO EVIDENCE TO SUGGEST THAT THE PATIENT'S DEATH WAS RELATED TO THE REPLACEMENT PROCEDURE OR THE PERFORMANCE OF THE DEVICE. THE DEVICE HAD BEEN RETURNED AND WAS FOUND TO MEET SPECIFICATION IN TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS DEVICE HAD SUFFERED FROM BREATHING ISSUES AND REPORTEDLY THEIR HEART HAD STOPPED FOR 17 MINUTES WHILE ON VACATION OUT OF THE COUNTRY SOMETIME NEAR THE "5 YEAR MARK" OF THE DEVICE BEING IMPLANTED. THE PATIENT WAS FLOWN BACK TO THE STATES TO A NEAREST MEDICAL CENTER WHERE THEY WENT ONTO THEIR LOCAL HOSPITAL. IT WAS NOTED THE PATIENT HAD TO BE CARDIOVERTED AND IT "DIDN'T TAKE." DURING THE EMERGENT HOSPITALIZATION THE PATIENT HAD UNDERWENT A DEVICE CHANGE OUT DUE TO THE BATTERY REACHING END OF LIFE (EOL). NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29291 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H210

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R 4542| N119| 4469| 0184| H210