BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3913569 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-09731
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    December 8, 2013
    Report Date
    April 22, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 HAD A BATTERY INDICATOR ANOMALY. AT A PREVIOUS DEVICE CHECK, THE DEVICE LONGEVITY REPORTED GOOD WITH ONE YEAR REMAINING HOWEVER, WITH A MAGNET RATE OF 90. FOLLOW-UPS WERE INTENSIFIED TO THREE MONTHS. APPROXIMATELY TWO MONTHS LATER, THE DEVICE DECLARED ELECTIVE REPLACEMENT TIME (ERT). THE PHYSICIAN REPORTED BEING CONFUSED DUE TO THE LACK OF A INDICATOR BETWEEN A LONGEVITY OF GOOD AND ERT. NO PREMATURE BATTERY DEPLETION (PBD) WAS ALLEGED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS EXPLANTED AND REPLACED SUCCESSFULLY DUE TO NORMAL BATTERY DEPLETION (NBD). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390800 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 1298