BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1944539 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19673
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 6, 2010
    Report Date
    March 23, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES ADVISED THAT THE DEVICE FOLLOW-UP INTENSIFY TO MONTHLY. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE AND RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE HAD A BATTERY MONITORING VOLTAGE OF 2.55 V AFTER APPROXIMATELY 55 MONTHS OF IMPLANT. THIS DEVICE IS PART OF THE SHORTENED REPLACEMENT WINDOW ADVISORY. THIS ADVISORY WAS ORIGINALLY COMMUNICATED (B)(6) 2007. A CLINICIAN QUESTIONED DEVICE LONGEVITY, AND DID NOT PROVIDE HISTORICAL BATTERY MONITORING VOLTAGE DATA FOR THE BOSTON SCIENTIFIC TECHNICAL SERVICES DEPARTMENT TO REVIEW.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H175

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention 4088| 4525| H175| 0185| 4087| 1290| 4518