BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4162336 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12796
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 17, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS SENSING INTEGRITY COUNTER (SIC). ANALYST COMMENTED, BEGINNING (B)(6) 2014, SENSING INTEGRITY COUNTS UP TO 1253; HIGH-RATE NON-SUSTAINED EPISODES WITH EVIDENCE OF LEAD NOISE OVERSENSING. ANALYSIS OF THE DEVICE MEMORY INDICATED THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RIGHT VENTRICULAR (RV) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. ANALYST COMMENTED, ON (B)(6) 2014, RV BIPOLAR LEAD IMPEDANCE MEASURED GREATER THAN 4047 OHMS. RVEAD INTEGRITY WARNING OCCURRED (B)(6) 2014 FOR SENSING INTEGRITY COUNTER GREATER THAN 30 IN 3 DAYS AND HIGH RATE NON SUSTAINED EVENTS.

    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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. CONCOMITANT PRODUCT: 419688 LEAD, IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS, OVERSENSING, NOISE AND HIGH IMPEDANCE WITH A POSSIBLE FRACTURE. THE RV LEAD WAS DEACTIVATED AND REPLACED WITH ANOTHER LEAD. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS, AND HIGH IMPEDANCE WITH A POSSIBLE FRACTURE. THE LV LEAD WAS DEACTIVATED AND REPLACED WITH ANOTHER LEAD. 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 (RV) LEAD EXHIBITED HIGH THRESHOLDS, OVERSENSING, NOISE AND HIGH IMPEDANCE WITH A POSSIBLE FRACTURE. THE RV LEAD WAS DEACTIVATED AND REPLACED WITH ANOTHER LEAD. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS, AND HIGH IMPEDANCE WITH A POSSIBLE FRACTURE. THE LV LEAD WAS DEACTIVATED AND REPLACED WITH ANOTHER LEAD. NO PATIENT COMPLICATIONSHAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639198 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R D394TRG ICD