BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS

    MDR report key: 1952546 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23438
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF NEW INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE. AS A RESULT, THE PHYSICIAN EXPLANTED THE LEAD AND REPLACED WITHOUT INCIDENT, ANOTHER BOSTON SCIENTIFIC LEAD. NO ADVERSE PATIENT EFFECTS REPORTED AND THE EXPLANTED LEAD IS NOT INTENDED TO BE RETURNED FOR POST MARKET EVALUATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS IMPLANTABLE LEAD NVN EXTERNAL MANUFACTURER 4137

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 4137| 1291| (B)(4)