BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1962302 · Received January 18, 2011

    Report

    Report Number
    2124215-2011-00792
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 29, 2010
    Report Date
    October 10, 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

    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

    AT THIS TIME, THIS DEVICE HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THIS DEVICE WAS EXPLANTED FOR AN UNKNOWN REASON. AT THIS TIME, THERE HAVE BEEN NO PRODUCT PERFORMANCE ALLEGATIONS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, UPON INTERROGATION, TACHYCARDIA THERAPY OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS FOUND TO BE PROGRAMMED OFF. IT WAS NOTED THAT SEVERAL MONTHS AGO, THIS PATIENT UNDERWENT A HEART VALVE REPLACEMENT PROCEDURE IN WHICH TACHYCARDIA THERAPY WAS TURNED OFF PURSUANT TO HOSPITAL PROCEDURES. TACHYCARDIA THERAPY WAS INADVERTENTLY NOT PROGRAMMED ON PRIOR TO THE PATIENT'S DISCHARGE FROM THE HOSPITAL. IT WAS QUESTIONED WHETHER THERE WAS A STUCK REED SWITCH., IF THERE WAS A STUCK REED SWITCH, THERE WOULD HAVE BEEN A MESSAGE ON THE SCREEN UPON INTERROGATION INDICATING THE DEVICE WAS IN THE PRESENCE OF A MAGNET. THERE WAS NO SUCH MESSAGE DISPLAYED UPON INTERROGATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE DEVICE WAS PROGRAMMED BACK ON. THE PATIENT HAD NO ADVERSE EFFECTS AS A RESULT OF THIS ISSUE. THE FIELD REPRESENTATIVE INDICATED THAT THE HOSPITAL IS REVIEWING THEIR PRE-DISCHARGE PROCEDURES FOR POST-SURGICAL PATIENTS TO ENSURE THERAPIES ARE TURNED ON (FOR ALL MANUFACTURERS). IT WAS NOTED THAT THE PATIENT'S HOSPITALIZATION WAS COMPLICATED AND LENGTHY WHICH CONTRIBUTED TO THE MISCOMMUNICATION BETWEEN HEALTH CARE PROFESSIONAL (HCP).

    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 53 YR 0184| 4524| H219| 4244