BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE

    MDR report key: 3053159 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05462
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 15, 2013
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WILL NOT BE RETURNED. 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 THIS CHRONIC RIGHT VENTRICULAR (RV) PACING LEAD WAS SURGICALLY ABANDONED AND REPLACED DURING A ROUTINE DEVICE REPLACEMENT PROCEDURE. THE LEAD EXHIBITED PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 2,500 OHMS, LOSS OF CAPTURE AT MAXIMUM OUTPUTS, AND NO SENSING. THE LEAD ISSUE WAS DISCOVERED WHEN A MAGNET APPLIED TO THE DEVICE DID NOT PRODUCE ASYNCHRONOUS PACING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156526 THINLINE IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 430-10

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R (B)(4)| 4074| (B)(4)| (B)(4)| 1198