BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZURE S DR MRI SURESCAN

    MDR report key: 9172851 · Received October 9, 2019

    Report

    Report Number
    3004209178-2019-19308
    Event Type
    Injury
    Date Received
    October 9, 2019
    Date of Event
    September 12, 2019
    Report Date
    October 9, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    UDI-DI
    00643169634602
    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: A7700-29 VALV,E IMPLANTED: (B)(6) 1998. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE GENERATOR CHANGE THE INCISION SITE DID NOT HEAL, LEAVING THE IMPLANTABLE PULSE GENERATOR (IPG) EXPOSED. THE IPG SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966511 AZURE S DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. W3DR01 00643169634602

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R 5076-52 LEAD, 5076-58 LEAD