BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2040113 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-00495
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    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

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S FAMILY MEMBER CONTACTED LATITUDE PATIENT SUPPORT TO REPORT THAT THIS DEVICE WAS EXPLANTED AND REPLACED WITH A COMPETITOR DEVICE. THE FAMILY MEMBER EXPLAINED THAT THE PHYSICIAN ELECTED TO REPLACE THE DEVICE BECAUSE OF PREMATURE BATTERY DEPLETION. TO DATE, THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY FOR ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R MISMATCH| 0185| 4087| 4555| H210