BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA SR MRI SURESCAN

    MDR report key: 8883160 · Received August 12, 2019

    Report

    Report Number
    3004209178-2019-15377
    Event Type
    Injury
    Date Received
    August 12, 2019
    Date of Event
    July 15, 2019
    Report Date
    August 21, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    UDI-DI
    00643169402669
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. RETURNED PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE DEVICE WAS RETURNED AND SCREENING ANALYSIS WAS PERFORMED, BUT NO ISSUE WAS IDENTIFIED REQUIRING FULL ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SYSTEMIC INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680176 ADVISA SR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. A3SR01 00643169402669

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R 5076-58 LEAD