BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA 300 DR

    MDR report key: 6196149 · Received December 21, 2016

    Report

    Report Number
    3004209178-2016-27002
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    December 10, 2016
    Report Date
    December 10, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS DECEASED. THE CAUSE OF DEATH WAS SEPSIS AND MYOCARDIAL INFARCTION. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED REGARDING THE SOURCE OF THE SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845004 SIGMA 300 DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO SDR303B

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death 5024M LEAD, 5568-45 LEAD