BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 3041198 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01073
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    May 13, 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

    THE DEVICE IS CURRENTLY UNDERGOING ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    --

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, DETAILED MECHANICAL AND ELECTRICAL TESTING WAS PERFORMED ON THE DEVICE. THE DEVICE BATTERY STATUS WAS ELECTIVE REPLACEMENT TIME (ERT). THE DEVICE FUNCTIONED NORMALLY THROUGHOUT TESTING. LABORATORY ANALYSIS DETERMINED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION; HOWEVER, THE ESTIMATED LONGEVITY REMAINING VALUE APPEARED TO DECREASE MORE QUICKLY THAN EXPECTED BETWEEN ROUTINE FOLLOW-UPS. FACTORS INFLUENCING THE ESTIMATED LONGEVITY REMAINING CALCULATION INCLUDE PACING RATE, AMPLITUDE, PULSE-WIDTH AND LEAD IMPEDANCE. ANY (EVEN SLIGHT) CHANGES IN THESE FACTORS WILL IMPACT THE BATTERY CONSUMPTION CALCULATION AND THEREFORE THE REMAINING LONGEVITY ESTIMATE. PLEASE NOTE THAT, DESPITE THE DROP IN ESTIMATED LONGEVITY REMAINING, THE ACTUAL BATTERY CONDITION DID NOT CHANGE SIGNIFICANTLY BETWEEN FOLLOW-UPS. IN SUMMARY, IT WAS DETERMINED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION, BUT DECLARED ERT EARLIER THAN PREVIOUSLY ESTIMATED.

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER WAS NEARING ELECTIVE REPLACEMENT TIME (ERT). THE HEALTH CARE PROVIDER (HCP) INDICATED THAT THE MAGNET RATES THAT WERE BEING SHOWN WERE FLUCTUATING BETWEEN 100 AND 90. NO PROGRAMMING CHANGES HAD BEEN MADE. THE PATIENT WILL BE SEEN FOR FOLLOW UP IN TWO MONTHS. THE DEVICE REMAINS IN SERVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THE DEVICE WAS EXPLANTED AND RETURNED BY ANOTHER MANUFACTURE'S REPRESENTATIVE.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    --

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142549 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R 4076| 1298| 4469