BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 4140446 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17607
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    February 21, 2013
    Report Date
    September 19, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SYSTEM WILL CONTINUE TO BE MONITORED VIA ROUTINE FOLLOW-UP. 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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), IMPLANTED WITH ANOTHER MANUFACTURER'S DEFIBRILLATION LEAD, EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. IN RV COIL TO CAN CONFIGURATION MEASUREMENTS WERE ACCEPTABLE. IT WAS NOTED THE MEASUREMENTS HAD BEEN HIGH OFF AND ON SINCE IMPLANT. THE PATIENT ALSO REPORTED HEARING BEEPING TONES SINCE IMPLANT. THE LEAD CONFIGURATION WAS PROGRAMMED TO RV COIL TO CAN. NON-INVASIVE PROGRAMMED STIMULATION (NIPS) WAS THEN PERFORMED AND YIELDED MEASUREMENTS OF 66 OHMS. THERE WAS A CONCERN THE SET SCREW WAS LOOSE, CAUSING THE HIGH OUT OF RANGE MEASUREMENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619251 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND N161

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R D154ATG| 4542| 6947| 5568| N161