BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1952730 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23764
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THE PACEMAKER REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN IMPLANT PROCEDURE TO IMPLANT A BOSTON SCIENTIFIC PACEMAKER, THE NON BOSTON SCIENTIFIC ATRIAL LEAD USED DURING THE PROCEDURE PERFORATED THE PATIENT'S ATRIUM. THE PATIENT REPORTED A FUNNY FEELING IN HER NEXK. AN ECHOGRAM AND CHEST X-RAY WERE PERFORMED AND A THORACOTOMY WAS DONE. THE PATIENT STARTED LOOSING A LOT OF BLOOD. THEN A STERNOTOMY WAS PERFORMED. THE ATRIAL LEAD HAD POKED ALL THE WAY THROUGH THE ATRIUM AND LEFT A LARGE HOLE. THE PHYSICIAN NOTED THE PATIENT HAD A VERY THIN ATRIAL WALL. THE DAMAGE TO THE ATRIAL WALL WAS REPAIRED AND A NEW ATRIAL LEAD WAS IMPLANTED WITH APPROPRIATE MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S602

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening