BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSIA DR

    MDR report key: 3900696 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-12233
    Event Type
    Death
    Date Received
    June 27, 2014
    Date of Event
    May 23, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE FUNERAL HOME AND NOTED THE CAUSE OF DEATH AS: NATURAL CAUSES.

    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

    AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A FUNERAL HOME INDICATING THE PATIENT IS DECEASED. FURTHER REVIEW OF THE MANUFACTURER¿S DATABASE INDICATED THE PATIENT IS DECEASED AND DIED APPROXIMATELY TWO MONTHS AFTER DEVICE SYSTEM IMPLANTED. ADDITIONAL INFORMATION OBTAINED FROM THE CARDIOLOGIST OFFICE REPORTED THE PATIENT HAD BEEN DISCHARGED TO A REHAB FACILITY TWO WEEKS PRIOR TO DEATH AFTER BEING TREATED FOR A GASTROINTESTINAL BLEED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378273 SENSIA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO SEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Death 4076-52 LEAD, 4076-45 LEAD