BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3210130 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06458
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 14, 2013
    Report Date
    June 25, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. THE DEVICE CASE WAS OPENED TO FACILITATE EXAMINATION OF THE INTERNAL COMPONENTS. UPON RECEIPT DEVICE DATA WAS INSUFFICIENT TO OBTAIN BATTERY STATUS AND THE DEVICE HAD NO TELEMETRY OR PACING OUTPUTS CONFIRMING THE REPORTED CLINICAL ALLEGATION. THE DEVICE BATTERY WAS REMOVED AND REPLACED WITH AN EXTERNAL POWER SOURCE. BATTERY VOLTAGE WAS NOTED TO BE LOWER THAN EXPECTED. DETAILED ANALYSIS OF THE DEVICE HYBRID WAS UNDERTAKEN. DURING PROBING OF THE HYBRID, THE HIGH CURRENT CONDITION DISAPPEARED. THE HYBRID WAS UNFOLDED AND MICROSCOPIC ANALYSIS DID NOT IDENTIFY ANY CONDITIONS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE IDENTIFIED HIGH CURRENT DRAIN OR LOWER THAN EXPECTED BATTERY VOLTAGE. THE HYBRID WAS TESTED IN MANY DIFFERENT CONDITIONS, AT MANY DIFFERENT TEMPERATURES AND THE HIGH CURRENT DRAIN COULD NOT BE REPRODUCED. ANALYSIS CONFIRMED THE INABILITY TO INTERROGATE THIS DEVICE AND IDENTIFIED A HIGH CURRENT DRAIN; HOWEVER, THE HIGH CURRENT DISAPPEARED DURING TESTING AND THE ROOT CAUSE COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, SURFACE ELECTROGRAM REVEALED INTRINSIC AV BLOCK AND NO DEVICE ACTIVITY. NO VISIBLE PACEMAKER SPIKES WERE NOTED AND TELEMETRY COULD NOT BE ESTABLISHED. THERE WAS NO RESPONSE TO A MAGNET APPLICATION. DURING THE PREVIOUS FOLLOW UP APPROXIMATELY EIGHT MONTHS EARLIER, BEGINNING OF LIFE (BOL) BATTERY STATUS WAS NOTED AND ALL DATA WAS NORMAL. A REPLACEMENT PROCEDURE WAS PERFORMED. THIS DEVICE WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310491 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S503

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R