BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3210985 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09096
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 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

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT IT WAS REPORTED THE PATIENT IMPLANTED WITH THIS PACEMAKER HAD CODED FOR SEVERAL MINUTES FOLLOWING A SUSPECTED BRADY EVENT. NO ELECTROGRAM (EGM) WAS RECORDED AT THE TIME OF THE EVENT. DISCUSSION WITH HOSPITAL STAFF, THE ISSUE WAS DESCRIBED AS A "WIDE BRADY COMPLEX" AND THE DEVICE WAS NOT PACING. THERE WERE NO EVENTS IN THE LOGBOOK ASSOCIATED WITH THE TIME OF THE EVENT. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310885 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S403

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| L| R S403| 4479| 4136