BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3905553 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-12872
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 20, 2014
    Report Date
    July 9, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR TESTING AND IS BEING EVALUATED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY. THIS PRODUCT ISSUE WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THIS DEVICE IDENTIFIED NO ANOMALIES. THE DF+ SETSCREW WAS STUCK IN THE UP POSITION. THIS SETSCREW WAS REMOVED AND BOTH THE SETSCREW AND ASSOCIATED CONNECTOR BLOCK WERE MICROSCOPICALLY EXAMINED. THE SETSCREW WAS CONFIRMED TO EXHIBIT SIGNS OF CROSS-THREADING. THE PACING AND SENSING FUNCTIONS OF THE DEVICE WERE VERIFIED PER AUTOMATED TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS SUCCESSFULLY REPOSITIONED. HOWEVER, THE LEAD WAS UNABLE TO BE ATTACHED TO THE DEVICE AS THE SET SCREW WOULD NOT DEPLOY, AND AFTER MULTIPLE ATTEMPTS THE SET SCREW WAS STRIPPED. A NEW DEVICE WAS IMPLANTED AND INTERFACED TO THE LEAD WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384801 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K172

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| L K172| 4137