BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2040741 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01066
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 11, 2011
    Report Date
    June 8, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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

    THE DEVICE WAS SUCCESSFULLY INTERROGATED BY BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CHARGE TIMES GREATER THAN THE CHARGE TIME LIMIT. END OF LIFE (EOL) WAS DECLARED FOLLOWING A SINGLE CHARGE TIME GREATER THAN 30 SECONDS. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE AND THE RESULTS INDICATED THE MONITORING VOLTAGE WAS NORMAL BASED ON THERAPY USE AND PROGRAMMED SETTINGS. IT WAS CONCLUDED THAT THIS DEVICE DID NOT EXPERIENCE PREMATURE BATTERY DEPLETION. RATHER, THE ERI TO EOL TIME PERIOD WAS SHORTENED DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE. THE DEVICE WAS CAPABLE OF DETECTING AND TREATING ARRHYTHMIAS, AS THE BATTERY ITSELF HAD SUFFICIENT CAPACITY REMAINING TO PROVIDE THERAPY IF NEEDED.

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM AN IMPLANT FORM THAT THIS PATIENT'S DEVICE WAS ELECTIVELY EXPLANTED DUE TO NORMAL BATTERY DEPLETION IN (B)(6) 2011. WHEN THE CHRONIC RIGHT ATRIAL (RA) LEAD WAS DISCONNECTED AND ATTACHED TO A PACING SYSTEM ANALYZER (PSA), THE MEASURED RA PACING IMPEDANCE WAS GREATER THAN 2000 OHMS. WHEN ATTACHED TO THE REPLACEMENT DEVICE, THE MEASURED RA PACING IMPEDANCE WAS GREATER THAN 2000 OHMS. THE RA LEAD WAS SURGICALLY CAPPED AND REPLACED WITH A COMPETITOR DEVICE. THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT FOR LABORATORY TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S LATITUDE MONITORING SYSTEM DETECTED A RED ALERT (DEVICE BATTERY HAS REACHED END OF LIFE (EOL). THE LOCAL REPRESENTATIVE WAS NOTIFIED OF THE ALERT. THE LATITUDE DATA UPLOAD WAS REVIEWED BY THE CLINIC NURSE. THE DEVICE MONITORING VOLTAGE WAS 2.55 VOLTS ASSOCIATED WITH A CHARGE TIME OF 31.5 SECONDS. THE AVAILABLE INFORMATION SUGGESTS THAT THE DEVICE REMAINS IN-SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H177

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R 0157| H177| 4479| 0158| T165| 4480