BEUDAMED
    FDA Adverse Event Death Summary report: N

    INGENIO

    MDR report key: 3913214 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-13527
    Event Type
    Death
    Date Received
    July 3, 2014
    Date of Event
    March 24, 2014
    Report Date
    July 3, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS CURRENTLY AVAILABLE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS PACEMAKER SYSTEM DIED. THE INFORMATION WAS RECEIVED FROM A PHYSICIAN WHO ALSO NOTED THAT THERE MAY HAVE BEEN EXTERNAL PATIENT HARM THAT CONTRIBUTED TO THE DEATH. REPORTEDLY THE DEVICE WAS EVALUATED AND THE PHYSICIAN WAS TOLD IT WAS NOT WORKING, AND NO FURTHER DETAILS WERE PROVIDED. THE INVESTIGATION WAS TURNED OVER TO THE POLICE, BUT DEVICE ANALYSIS WAS REQUESTED AS IT MAY HELP TO DETERMINE THE CAUSE OF DEATH. AT THIS TIME, THE DEVICE HAS NOT BEEN RETURNED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE THAT THE LAST EVALUATION HE PERFORMED ON THE DEVICE WAS NORMAL, AND IT OCCURRED THE DAY POST IMPLANT. IT WAS NOTED THE PATIENT DID NOT APPEAR TO BE PACEMAKER DEPENDENT AT THE TIME OF THAT EVALUATION. THE FIELD REPRESENTATIVE HAD NOT BEEN CONTACTED TO EVALUATE THE DEVICE AGAIN AND HAD NO INFORMATION RELATED TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THE IMPLANTING PHYSICIAN DID NOT BELIEVE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. HOWEVER, THE CAUSE OF DEATH WAS NOT PROVIDED. AT THIS TIME, THE DEVICE HAS NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390751 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death 4137| 4136| K173