BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 8685975 · Received June 11, 2019

    Report

    Report Number
    2649622-2019-09931
    Event Type
    Injury
    Date Received
    June 11, 2019
    Date of Event
    May 15, 2019
    Report Date
    June 25, 2019
    Manufacturer
    MPRI
    Product Code
    NVN
    UDI-DI
    00643169857681
    PMA / PMN Number
    P030036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED. PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE PROXIMAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY FRACTURED DUE TO MELTING. THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO MELTING. VISUAL ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. 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 RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE RV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482252 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 383069 00643169857681

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R ADDRL1 IPG, 5076-45 LEAD