BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADAPTA DR

    MDR report key: 4949776 · Received July 29, 2015

    Report

    Report Number
    3004209178-2015-14264
    Event Type
    Death
    Date Received
    July 29, 2015
    Date of Event
    June 25, 2015
    Report Date
    July 6, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS DECEASED AND DIED APPROXIMATELY 7 YEARS AFTER IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM. IT WAS ALSO REPORTED THAT THE PATIENT'S DAUGHTER ALLEGES THAT THE IPG SYSTEM CONTRIBUTED TO THE PATIENT'S DEATH. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493893 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Death 5076-45 LEAD, 5076-52 LEAD