BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2910085 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15058
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    October 22, 2012
    Report Date
    June 6, 2016
    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

    OUR RECORDS INDICATE THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE DEVICE MEMORY WAS SUBMITTED TO ENGINEERING FOR ANALYSIS. THE ANALYSIS DETERMINED THAT THERE WAS 2.4 YEARS REMAINING ON THIS DEVICE TO ERI AND THE DEVICE IS ON A CURRENT BIN BOUNDARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE DISPLAYED LONGEVITY ESTIMATES THAT WERE INCONSISTENT. A TECHNICAL SERVICE (TS) CONSULTANT WAS CONTACTED REGARDING THIS ISSUE AND DISCUSSED THE CHARGE BINS AND HOW THE LONGEVITY WILL CHANGE BASED ON THE CURRENT OUTPUT. TS INDICATED THAT THE DEVICE WAS WORKING AS PROGRAMMED OTHERWISE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS TO BE SEEN FOR A ROUTINE FOLLOW UP APPOINTMENT. DUE TO PREVIOUS INCONSISTENT LONGEVITY, DEVICE MEMORY WAS SAVED TO A DISK FOR FURTHER REVIEW. THE ANALYSIS WAS REVIEWED AND IT WAS CONFIRMED THAT THE DEVICE WAS OPERATING WITH THE AUTOMATIC CAPTURE (AC) FEATURE ACTIVATED. DATA IN THE MEMORY CONFIRMED THAT THE DEVICE HAD ENTERED RETRY MODE AND THE DEVICE OUTPUT VOLTAGE WAS SUSPENDED AT 5.0 V. THE DEVICE DISPLAYED A PREDICTED 8.8 MONTHS REMAINING LONGEVITY. TECHNICAL SERVICES WAS CONSULTED AND RECOMMENDED TURNING OFF AC AND ACTIVATING A FIXED VALUE TO PREVENT RETRY. NO FURTHER INFORMATION WAS AVAILABLE. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THIS DEVICE DECLARED END OF LIFE (EOL). AN INVASIVE PROCEDURE WAS PERFORMED TO EXPLANT AND REPLACE THE DEVICE. 7 MONTHS PRIOR TO DECLARING EOL, THE DEVICE LONGEVITY WAS REPORTEDLY AT 2 YEARS REMAINING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16279 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 266 MO Hospitalization| L| R 4136| 4469| 4470