BEUDAMED
    FDA Adverse Event Death Summary report: N

    N/A

    MDR report key: 2859219 · Received December 5, 2012

    Report

    Report Number
    3004209178-2012-11240
    Event Type
    Death
    Date Received
    December 5, 2012
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE IMPLANTABLE PULSE GENERATOR SYSTEM WAS RETURNED WITH NO INFORMATION. A DATABASE SEARCH BY SERIAL NUMBER REVEALED THE PATIENT TO BE DECEASED. THE DEATH OCCURRED LESS THAN ONE YEAR AFTER IMPLANT. FOLLOW UP HAS BEEN INCONCLUSIVE AND NO FURTHER CONTACTS ARE KNOWN. NO COMPLAINTS, ALLEGATIONS, OR PREVIOUS CONTACTS HAVE BEEN RECEIVED IN REGARDS TO THE DEVICE SYSTEM OR ANY OF THE INDIVIDUAL COMPONENTS.

    Description of Event or Problem · 1

    THE IMPLANTABLE PULSE GENERATOR SYSTEM WAS RETURNED WITH NO INFORMATION. A DATABASE SEARCH BY SERIAL NUMBER REVEALED THE PATIENT TO BE DECEASED. THE DEATH OCCURRED LESS THAN ONE YEAR AFTER IMPLANT. FOLLOW UP HAS BEEN INCONCLUSIVE AND NO FURTHER CONTACTS ARE KNOWN. NO COMPLAINTS, ALLEGATIONS, OR PREVIOUS CONTACTS HAVE BEEN RECEIVED IN REGARDS TO THE DEVICE SYSTEM OR ANY OF THE INDIVIDUAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO VEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Death