BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3904575 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09909
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 DURING A RECENT COLONOSCOPY PROCEDURE THIS PATIENT'S HEART RATE HAD A SUDDEN JUMP TO 120 BEATS PER MINUTE (BPM). THE DEVICE WAS THEN INTERROGATED AND THE HEART RATE RETURNED TO NORMAL. THE TELEMETRY EQUIPMENT IN THE ROOM AS LIKELY THE CAUSE OF THE HIGH RATE PACING. THE PATIENT WAS NOT SYMPTOMATIC TO THE HIGH RATE PACING AS IT WAS ONLY FOR A SHORT DURATION. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382440 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 1688TC| S603