BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2153646 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06688
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    March 24, 2011
    Report Date
    April 7, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE SALES REPRESENTATIVE WHO SPOKE WITH THE PATIENT'S PHYSICIAN. THE PHYSICIAN INDICATED THE PATIENT WAS ON BLOOD THINNER PRIOR TO THE PROCEDURE. THE BLOOD THINNER WAS STOPPED A FEW DAYS PRIOR TO THE PROCEDURE AND RESTARTED THE DAY AFTER THE PROCEDURE. THE PHYSICIAN FEELS THE HEMATOMA AND POCKET EVACUATIONS WERE DUE TO THE BLOOD THINNER MEDICATIONS. LATITUDE PATIENT SERVICES ADVISED THE PATIENT TO FOLLOW UP WITH HER PHYSICIAN AND SENT LITERATURE TO THE PATIENT REGARDING HER PACEMAKER. IF FURTHER INFORMATION BECOMES AVAILABLE THIS EVENT WILL BE REOPENED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE PULSE GENERATOR (PG) EXPERIENCED SWELLING, BLEEDING AND DISCOMFORT. THE PATIENT DEVELOPED A HEMATOMA THAT REQUIRED DRAINING. THERE ARE NO ALLEGATIONS AGAINST THE DEVICE.

    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 76 YR Life Threatening| R S602| 4068| 4024| MISMATCH