BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZURE XT DR MRI SURESCAN

    MDR report key: 20494043 · Received October 21, 2024

    Report

    Report Number
    3008973940-2024-07737
    Event Type
    Injury
    Date Received
    October 21, 2024
    Date of Event
    September 27, 2024
    Report Date
    October 21, 2024
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    UDI-DI
    00763000316846
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 1368 ST-JUDE-LEAD: IMPLANTED ON (B)(6) 2002. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED APPROXIMATELY ONE MONTH POST IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM, THE PATIENT EXPERIENCED POCKET INFECTION. THE PATIENT ALSO HAD REDNESS. THE IPG SYSTEM WAS EXPLANTED. A TEMPORARY LEAD WAS IMPLANTED VIA INTERNAL JUGULAR VEIN AND CONNECTED TO THE PATIENT'S EXPLANTED IPG WHICH WAS TAPED TO THEIR NECK AS THEY ARE PACEMAKER DEPENDENT.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2219584 AZURE XT DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS W1DR01 00763000316846

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Hospitalization| R 1488 ST-JUDE-LEAD