BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZURE

    MDR report key: 8387281 · Received March 4, 2019

    Report

    Report Number
    9614453-2019-00651
    Event Type
    Injury
    Date Received
    March 4, 2019
    Date of Event
    February 8, 2019
    Report Date
    March 4, 2019
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    NVZ
    UDI-DI
    00643169871939
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 3093-28 INTERSTIM URINARY MGU LEAD IMPLANTED: (B)(6) 2009; 3058 INTERSTIM URINARY MGU IPG IMPLANTED: (B)(6) 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACEMAKER SYSTEM WAS REMOVED DUE TO A POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181279 AZURE PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC EUROPE SARL W1DR01 00643169871939

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R 407652 LEAD, 407645 LEAD