BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3905425 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11208
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    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 THE PRE-DISCHARGE CHECK THE RIGHT ATRIAL (RA) LEAD WAS FOUND TO BE DISLODGED. SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED WHERE THE LEAD WAS SUCCESSFULLY REPOSITIONED. THE FOLLOWING DAY IT WAS NOTED THAT THE P-WAVES WERE GREATER THAN THE R-WAVES AND THE SURFACE REVEALED THAT THE RA AND RIGHT VENTRICULAR (RV) LEADS WERE REVERSED IN THE HEADER OF THE DEVICE. A REVISION PROCEDURE TO CORRECT THE REVERSAL WAS SUCCESSFULLY PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383549 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K063

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| L| R 4469| 4470| K063