BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADAPTA

    MDR report key: 3072710 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06736
    Event Type
    Death
    Date Received
    April 23, 2013
    Date of Event
    January 23, 2013
    Report Date
    March 26, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS ONE OF TWO DEVICE SYSTEMS REPORTING THE DEATH OF THIS PATIENT. ADDITIONAL INFORMATION OBTAINED INDICATED THE PREVIOUS SYSTEM WAS REMOVED DUE TO INFECTION AND THE PATIENT WAS STILL UNDER TREATMENT FOR INFECTION WHEN THIS DEVICE WAS IMPLANTED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE DEATH HAS ALSO BEEN REPORTED UNDER THE FOLLOWING REGULATORY REPORT NUMBERS: 3004209178-2013-06732, 2649622-2013-05311, 2649622-2013-05312. (B)(4). CONCOMITANT PRODUCT: 1888TC COMPETITOR IMPLANTABLE PACING LEAD IMPLANTED, (B)(6) 2013; 1888TC COMPETITOR IMPLANTABLE PACING LEAD IMPLANTED, (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED AND DIED APPROXIMATELY ONE WEEK POST IMPLANTABLE PULSE GENERATOR IMPLANT. THE CAUSE OF DEATH WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175121 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Death