BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSIA D

    MDR report key: 2562429 · Received May 7, 2012

    Report

    Report Number
    6000094-2012-00957
    Event Type
    Death
    Date Received
    May 7, 2012
    Date of Event
    January 30, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE CAUSE OF DEATH IS UNKNOWN AND WILL NOT BE KNOWN. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED FOR MODELS: 5076 AND 5592.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT, A PARTICIPANT IN "PANORAMA OS," IS DECEASED. FURTHER INFORMATION RECEIVED INDICATES THE PATIENT DIED APPROXIMATELY TWO AND ONE HALF MONTHS POST IMPLANT OF A DUAL CHAMBER IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA D IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. SED01

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death