BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3050013 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-05525
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 21, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN

    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 THIS PATIENT'S PACER MIGRATED DOWN NEAR THE BREAST DUE TO ADIPOSE TISSUE. (IT WAS INDICATED THAT ADIPOSE TISSUE IS TYPICALLY A POOR ANCHOR FOR DEVICES.) IT WAS THOUGHT THAT THIS DEVICE MIGRATION PULLED THE SLACK OUT OF THE ATRIAL LEAD AND EVENTUALLY BECAME TOO TIGHT, THEREBY LEADING TO LEAD DISLODGEMENT. A NEW POCKET WAS CREATED, AND THE PACER WAS MOVED TO THE NEW POCKET, WHICH WAS HIGHER UP AND CLOSER TO THE LEFT CLAVICLE. IT WAS THOUGHT THAT THIS NEW PLACEMENT WAS SUBMUSCULAR. THE OLD POCKET WAS CLOSED TIGHTLY WITH TWO RUNNING STITCHES. THE PATIENT WAS DOING WELL AFTER THIS REVISION PROCEDURE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149032 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 4470| 4471| K173