BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE MRI SURESCAN

    MDR report key: 4161324 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11560
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 2, 2014
    Report Date
    January 22, 2020
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED AND THERE WERE NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. THE ANALYSIS INDICATED THAT THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. THE INTERIOR SUPERIOR VENA CAVA DEFIBRILLATION CABLE DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. THE OUTER INSULATION OF THE LEAD WAS BREACHED DUE TO BI/MULTI-LUMEN TUBING VOIDS WHILE IN VIVO. THE ANALYST NOTED THAT THE LEAD WAS RECEIVED IN PIECES DISTAL CONDUCTOR WAS FRACTURED WITH THE FIRST 20 CM OF THE CONNECTOR PIN. THE INTERIOR SUPERIOR VENA CAVA DEFIBRILLATION WAS FRACTURED AT THE CROSS GROOVE OF THE EXPOSED DEFIB COIL. AND THE OUTER INSULATION WAS BREACHED THROUGHOUT THE LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: DDBB1D1 ICD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI) DEVICE CHANGEOUT, THE DEVICE HAD SIGNIFICANT CALCIFICATION CAUSING DIFFICULTY DISSECTING THE DEVICE AND LEADS. THE RIGHT VENTRICULAR (RV) LEAD COIL INSULATION WAS DAMAGED AND REPLACED WITH SILICONE AND PLASTIC SLEEVES. IT WAS NOTED THAT INITIALLY IMPEDANCE LEVELS TESTED NORMAL. AFTER THE POCKET WAS CLOSED, HIGH IMPEDANCE WITH POSSIBLE FRACTURE WAS NOTED, ALONG WITH UNSUCCESSFUL DEFIBRILLATION THRESHOLD TESTING. THE POCKET WAS REOPENED AND RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEAD WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641859 SPRINT QUATTRO SECURE MRI SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR Hospitalization| R 5568-45 LEAD