BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSIA SR

    MDR report key: 5233819 · Received November 18, 2015

    Report

    Report Number
    3008973940-2015-00543
    Event Type
    Death
    Date Received
    November 18, 2015
    Date of Event
    October 13, 2015
    Report Date
    October 22, 2015
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED AND DIED SIX DAYS POST DEVICE REPLACEMENT. IT WAS FURTHER REPORTED THAT THE DAY PRIOR TO THE DEATH, THE PATIENT WENT TO THE PHYSICIAN WITH COLD LIKE SYMPTOMS, WAS PRESCRIBED A MEDICATION AND RETURNED HOME. THE PATIENT WAS FOUND THE FOLLOWING MORNING BY A FAMILY MEMBER AND EMERGENCY SERVICES WAS CONTACTED. IT WAS REPORTED THAT AN EXTERNAL ELECTROCARDIOGRAM (EKG) WAS PERFORMED BY EMERGENCY SERVICES STAFF AND NO PACING SPIKES WERE PRESENT AND NO ELECTRICAL ACTIVITY WAS NOTED ON THE EKG. A DEVICE MALFUNCTION IS ALLEGED. NO AUTOPSY WAS PERFORMED AND THE PATIENT WAS BURIED WITH THE DEVICE SYSTEM. ADDITIONAL INFORMATION RECEIVED NOTED THAT NO PERFORMANCE ISSUES WERE PRESENT ON THE POST IMPLANT EKG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764668 SENSIA SR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS SESR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Death| R 5092-58 LEAD