BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSIA DR

    MDR report key: 2122384 · Received June 13, 2011

    Report

    Report Number
    6000094-2011-01271
    Event Type
    Death
    Date Received
    June 13, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE FOREIGN SOURCES AND NOT YET RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A FOREIGN STUDY THAT THE PATIENT DIED IN THE HOSPITAL FROM A "NON-SUDDEN CARDIAC DEATH." THE DEATH OCCURRED LESS THAN TWO MONTHS POST IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED IN REGARDS TO THE CAUSE OF DEATH AND CIRCUMSTANCES SURROUNDING THE DEATH AND HAS NOT BEEN RECEIVED. NO COMPLAINTS OR ALLEGATION HAVE BEEN MADE AGAINST THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. SEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| O