BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2953173 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00939
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    February 19, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PRODUCT PERFORMANCE INFORMATION WAS RECEIVED, ANALYZED, AND THE RIGHT VENTRICULAR (RV) PACING IMPEDANCE WAS UNDEFINED. THE DAILY RV PACE IMPEDANCE VARIES BETWEEN 1000 AND GREATER THAN 3000 OHMS FOR THE 14 DAYS RECORDED (B)(6) 2012 TO (B)(6) 2012. THE WEEKLY MAXIMUM RV PACE IMPEDANCE AVERAGES APPROXIMATELY 1000 OHMS FOR 78 WEEKS WITH A MAXIMUM OF APPROXIMATELY 2000 FOR THE WEEK ENDING (B)(6) 2012 AND GREATER THAN 3000 FOR THE WEEK ENDING (B)(6) 2012. OVERSENSING/NOISE WAS ALSO NOTED AS 14 VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODE OCCURRED BETWEEN (B)(6) 2012 AND (B)(6) 2013 WITH THE AVERAGE CYCLE LENGTH LESS THAN 210 MS. ALERTS WERE ALSO NOTED TO BE TRIGGERED. OUR LEAD INTEGRITY ALERTS OCCURRED BETWEEN (B)(6) 2012 AND (B)(6) 2012. ONE ALERT OCCURRED FOR OUT OF RANGE LEAD IMPEDANCE ON (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND THE DISTAL CONDUCTOR WAS FLEXED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT VENTRICULAR LEAD HAD HIGH IMPEDANCE AND WAS OVERSENSING. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT VENTRICULAR LEAD HAD HIGH IMPEDANCE AND WAS OVERSENSING. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT VENTRICULAR LEAD HAD HIGH IMPEDANCE AND WAS OVERSENSING. THE 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
    56958 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization| R