BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 4140004 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16268
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    August 29, 2014
    Report Date
    October 6, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. IT WAS CONFIRMED THE RV- SETSCREW WAS STUCK IN THE FULLY LOOSENED POSITION. THE SETSCREW WAS LOOSENED WITH 21 INCH OUNCES OF FORCE WHICH IS A HIGHER FORCE THAN IS CAPABLE OF BEING EXERTED BY THE WRENCH RECOMMENDED FOR USE WITH THIS DEVICE. THIS INDICATES THIS SETSCREW WAS OVER-TORQUED BY THE USE OF A WRENCH OTHER THAN THE RECOMMENDED WRENCH. LABORATORY ANALYSIS DETERMINED THE SETSCREW BECAME STUCK IN THE LOOSENED POSITION DURING EITHER THE IMPLANT OR REVISION PROCEDURE. IF IT WAS STUCK DURING THE IMPLANT PROCEDURE, THIS WOULD HAVE CONTRIBUTED TO THE OBSERVED OVERSENSING AND LOSS OF CAPTURE.

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOWING RETURN AND COMPLETION OF LABORATORY ANALYSIS ON THE EXPLANTED DEVICE, THIS EVENT WILL BE FURTHER UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE AND RIGHT VENTRICULAR LEAD, SOUGHT MEDICAL ATTENTION DUE TO FEELING DIZZY. AN INTERROGATION CONFIRMED LOSS OF RIGHT VENTRICULAR (RV) CAPTURE AND SYSTEM OVERSENSING. SURGICAL INTERVENTION ILLUSTRATED A SETSCREW CONNECTION ANOMALY WITH THE RV LEAD TERMINAL PIN AND THE DEVICE. THE PHYSICIAN WAS UNABLE TO REESTABLISH THE CONNECTION AND ELECTED TO EXPLANT THE CHRONIC DEVICE. ANOTHER BOSTON SCIENTIFIC DEVICE WAS SUCCESSFULLY CONNECTED TO THE CHRONIC RV LEAD AND THE PROCEDURE COMPLETED WITH NO ADVERSE PATIENT EFFECTS. THE EXPLANTED DEVICE IS INTENDED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620190 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 0986

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R S503| 4341| 0986