BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3790220 · Received May 5, 2014

    Report

    Report Number
    2124215-2014-03981
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    January 24, 2014
    Report Date
    April 21, 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

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. IT WAS NOTED THAT THE DEVICE BATTERY MONITORING VOLTAGE WAS 2.8 VOLTS. THE DEVICE CASE WAS OPENED TO FACILITATE EXAMINATION OF THE INTERNAL COMPONENTS. THE DEVICE BATTERY WAS REMOVED AND REPLACED WITH AN EXTERNAL POWER SOURCE. A HIGH CURRENT CONDITION WAS IDENTIFIED. 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. 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING ROUTINE PATIENT FOLLOW-UP, THE PHYSICIAN WAS NOT ABLE TO INTERROGATE THIS PACEMAKER. NO ASYNCHRONOUS PACING WAS OBSERVED DURING MAGNET APPLICATION. OTHER ELECTRICAL PARAMETERS WERE IN WITHIN NORMAL LEVELS. THE PATIENT IS NOT PACEMAKER DEPENDENT BUT REPORTED ONE EPISODE OF DIZZY SPELL OVER THE LAST PERIOD. THIS BRADY DEVICE IS NO LONGER IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267672 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S501

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R 5076| S501