BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1953741 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24622
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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 THE PATIENT EXPERIENCED SYNCOPE AND WAS NOTED TO BE PACING BELOW THE PROGRAMMED LOWER RATE LIMIT FIVE PERCENT OF THE TIME. UPON INTERROGATION OVER NINE THOUSAND PREMATURE VENTRICULAR CONTRACTIONS WERE OBSERVED ALONG WITH SEVERAL ECTOPIC BEATS, ALL LEAD DIAGNOSTICS WERE WITHIN NORMAL LIMITS. BOSTON SCIENTIFIC TECHNICAL SERVICES DISCUSSED TIMING OPTIONS WITH THE SALES REPRESENTATIVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening 4076| S603