BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1951528 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23270
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 11, 2010
    Report Date
    December 20, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY ANALYZED. VISUAL INSPECTION NOTED THAT A LEAD TERMINAL PIN WAS RETURNED IN BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) PORTS AND BOTH DISTAL SETSCREWS WERE TIGHTENED AGAINST THE PINS. THE SETSCREWS WERE ABLE TO BE DISENGAGED WITHOUT ISSUE AND THE TERMINAL PINS WERE REMOVED WITHOUT DIFFICULTY. ALL OTHER SETSCREWS MOVED FREELY AND WITHOUT ISSUE. MICROSCOPIC ANALYSIS FOUND THAT THE RV PROXIMAL SEAL PLUG WAS MISSING AND THE RETAINER RING WAS BENT UPWARD. THIS DAMAGE IS INDICATIVE OF EXCESSIVE FORCE BEING APPLIED TO THE SETSCREW IN ORDER TO RETRACT IT. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LABORATORY ANALYSIS CONFIRMED THE FIELD OBSERVATION THAT ONE OF THE SETSCREWS BECAME STUCK DURING THE EXPLANTATION PROCEDURE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS SUCCESSFULLY EXPLANTED AND WILL BE RETURNED FOR LABORATORY ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE. ONCE THIS DEVICE IS RETURNED AND ANALYSIS COMPLETED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED DUE TO A SUSPECTED INFECTION. DURING THE PROCEDURE, ONE OF THE SETSCREWS BECAME STUCK AND COULD NOT BE LOOSENED. IT WAS ALSO REPORTED THAT THE PHYSICIAN USED A COMPETITOR'S WRENCH. NO OTHER 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 M170

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R