BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSIA SR

    MDR report key: 3200769 · Received July 1, 2013

    Report

    Report Number
    9614453-2013-01464
    Event Type
    Death
    Date Received
    July 1, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. NO ADDITIONAL INFORMATION IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED AND DIED APPROXIMATELY THREE MONTHS POST IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS FURTHER REPORTED THAT ON THE DAY OF DEATH THE PATIENT FELT UNCOMFORTABLE AND THEN ¿SOME SOUND LIKE EXPLODE WAS HEARD (ACCORDING TO PATIENT¿S FAMILY)." ADDITIONAL INFORMATION OBTAINED NOTED THE CAUSE OF DEATH WAS UNKNOWN AND WAS DETERMINED AS ¿SUDDEN DEATH.¿ THERE WAS NO ALLEGATION BY THE PHYSICIAN RELATED TO THE DEVICE. POST MORTEM INTERROGATION OF THE DEVICE REPORTED NORMAL FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300466 SENSIA SR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SESR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Death