BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2053119 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03950
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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 THE PATIENT IMPLANTED WITH THIS DEVICE WAS EXPOSED TO A TENS UNIT DURING A CHIROPRACTIC CARE VISIT AND RECEIVED INAPPROPRIATE THERAPY FROM THE DEVICE. NON-SUSTAINED EPISODES ALSO OCCURRED AT THE SAME TIME WITH PREVIOUS TENS THERAPY RECEIVED. THIS PACER DEPENDENT PATIENT EXPERIENCED ASYSTOLE FOR APPROXIMATELY FIVE SECONDS BEFORE THE DEVICE DELIVERED THERAPY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H219

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 5076| 0184| 4525| 1280| 4471| 4470| 1290| 5554| H219