BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE MRI SURESCAN

    MDR report key: 2951952 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00315
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 8, 2012
    Report Date
    August 9, 2021
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WAS A PATIENT ALERT FOR OUT OF TOLERANCE SUB-THRESHOLD LEAD IMPEDANCE ON (B)(6) 2012. THE DAILY PACE LEAD TREND DATA SHOWED AN INCREASE FOR SUPERIOR VENA CAVA (SVC) IMPEDANCE FROM 62 TO 104 OHMS BETWEEN (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    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 SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE TRIGGERED AN ALERT FOR BEING OUT OF RANGE. THE IMPEDANCE TREND SHOWED A SUDDEN INCREASE TO A HIGH MEASUREMENT. THE RIGHT VENTRICULAR (RV) LEAD COIL WAS SLIGHTLY HIGHER THAN IT HAD BEEN. THE SVC COIL WAS PROGRAMMED TO OFF AND THE LEAD REMAINS IN USE. 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 EXHIBITED SLOWLY INCREASING PACING IMPEDANCES TO HIGH LEVELS. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57398 SPRINT QUATTRO SECURE MRI SURESCAN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC| (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC