BEUDAMED
    FDA Adverse Event Death Summary report: N

    DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES

    MDR report key: 2982499 · Received February 28, 2013

    Report

    Report Number
    2649622-2013-02486
    Event Type
    Death
    Date Received
    February 28, 2013
    Date of Event
    May 29, 2012
    Report Date
    January 30, 2013
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. ATTEMPT(S) FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL WITH BOTH THE PHYSICIAN OFFICE AND THE FUNERAL HOME. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD (B)(6) 2012. (B)(4). THE LEAD WAS NOT RETURNED TO THE MANUFACTURER AND WILL NOT BE EVALUATED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTED AS DECEASED BY A FAMILY MEMBER. THE CALLER INDICATED THE PATIENT DIED APPROXIMATELY EIGHT DAYS POST IMPLANT OF THE ICD SYSTEM AND INQUIRED IF THE DEVICE AND LEAD WERE RECALLED. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87721 DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 Death (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR