BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2812177 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16911
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PRODUCT PERFORMANCE INFORMATION WAS COLLECTED AND ANALYZED. ANALYSIS FOUND FIVE LEAD FAILURE PREDICTOR HIGH RATE NON-SUSTAINED EPISODES <(><<)>(> <(><<)><(><<)>)>= 187 MS AVERAGE VENTRICULAR CYCLE LENGTH BETWEEN (B)(6) 2012 12:23:43 AND (B)(6) 2012 13:00:11. TWO PATIENT ALERTS FOR LEAD FAILURE PREDICTOR OCCURRED ON (B)(6) 2012. THE VENTRICULAR SHORT INTERVAL COUNT WAS 275 COUNTS, IN 9.04 DAYS, BETWEEN (B)(6) 2012. THE WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS A SPIKE INCREASE FOR MAX VENTRICULAR PACE BIPOLAR IMPEDANCE FROM 494 TO 931 OHMS PEAK BETWEEN (B)(6) 2012, THEN RETURNING TO 456 OHMS ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD AN APPARENT FRACTURE AS A LEAD INTEGRITY ALERT WAS TRIGGERED FOR OVERSENSING AND VARYING IMPEDANCE. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD AN APPARENT FRACTURE AS A LEAD INTEGRITY ALERT WAS TRIGGERED FOR OVERSENSING AND VARYING IMPEDANCE. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R