BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSIA DR

    MDR report key: 4012126 · Received August 15, 2014

    Report

    Report Number
    9614453-2014-02032
    Event Type
    Death
    Date Received
    August 15, 2014
    Date of Event
    July 19, 2014
    Report Date
    October 24, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE.

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS DECEASED. THE PATIENT IS REPORTED TO HAVE BEEN ON HOLIDAY WHEN ENTERED A DISCO AND APPROACHED ¿BIG LOUDSPEAKERS¿. THE PATIENT SAT ON THE GROUND, LOST CONSCIOUSNESS AND DIED. THE PHYSICIAN INQUIRED IF THE SPEAKERS INTERFERED WITH DEVICE FUNCTION. NO AUTOPSY WAS OR WILL BE PERFORMED AND THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490928 SENSIA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR Death