BEUDAMED
    FDA Adverse Event Death Summary report: N

    INGENIO

    MDR report key: 3132586 · Received May 29, 2013

    Report

    Report Number
    2124215-2013-08618
    Event Type
    Death
    Date Received
    May 29, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 30, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 A PATIENT VERIFICATION FORM IN MEDICAL RECORDS THAT WAS FILLED OUT BY THE PATIENT'S BROTHER-IN-LAW. THE FORM HAD A HAND WRITTEN LIST OF MEDICAL CONDITIONS THE PATIENT HAD, SUCH AS: OPEN HEART SURGERY, SLIGHT STROKE, PACEMAKER LEFT SIDE, PACEMAKER RIGHT SIDE, PUNCTURED LUNG, PNEUMONIA, INFECTION, BACTERIAL BLOOD INFECTION AND SEPSIS. THE FORM STATED THE PATIENT PASSED AWAY IN EARLY (B)(6) 2013 (APPROXIMATELY TWO MONTHS POST-IMPLANT). ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE. HE STATED THE LIST OF CONDITIONS WOULD NOT HAVE BEEN A RESULT OF THE IMPLANT PROCEDURE AS THE PHYSICIAN'S OFFICE WAS NOT AWARE OF THESE CONDITIONS OR THE PATIENT'S DEATH. THE FIELD REPRESENTATIVE CONFIRMED THE DEVICE WAS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236695 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K063

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death 4136| K063| 4135