BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 3790103 · Received May 5, 2014

    Report

    Report Number
    2124215-2014-07812
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 19, 2014
    Report Date
    May 14, 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

    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

    (B)(4). AVAILABLE INFORMATION SUGGESTS THAT THE DEVICE WILL NOT BE RETURNED. 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 PACEMAKER WAS SUSPECTED TO HAVE PREMATURE BATTERY DEPLETION (PBD). A YEAR AGO, THE DEVICE LONGEVITY ESTIMATION WAS THREE YEARS BUT CURRENTLY DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI). A DEVICE CHANGED OUT WAS NOT PERFORMED YET. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. THE DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266968 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R (B)(4)