BEUDAMED
    FDA Adverse Event Death Summary report: N

    N/A

    MDR report key: 2913562 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-00517
    Event Type
    Death
    Date Received
    January 14, 2013
    Date of Event
    June 22, 2012
    Report Date
    November 28, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Adverse Event
    Yes
    Product Problem
    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. EVENT SUMMARY (B)(4) -THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. ANALYSIS REVEALED ELECTRICAL OVERSTRESS OF THE HYBRID. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN'S NURSE INDICATED THE PATIENT WAS LAST SEEN FOR A DEVICE SYSTEM CHECK APPROXIMATELY TWO MONTHS PRIOR TO DEATH; THE DEVICE WAS "FUNCTIONING FINE." FURTHER INDICATED THE PATIENT WAS ON HOME HOSPICE, IT IS UNKNOWN WHO THE HOSPICE PROVIDER WAS. THE CAUSE OF DEATH IS UNKNOWN. (B)(4). CONCOMITANT MEDICAL PRODUCTS: 5076-52 IMPLANTABLE PACING LEAD, (B)(6) 2011.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20132 N/A PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Death 5076-45 IMPLANTABLE PACING LEAD