BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 4161354 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11547
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    May 14, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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 PRODUCTS: 5076-58 LEAD, IMPLANTED: (B)(6) 2014; 419488 LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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). ANALYSIS OF THE DEVICE MEMORY INDICATED THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET. ANALYST COMMENTED, 251 LIFETIME VENTRICULAR SIC ARE RECORDED BEGINNING (B)(4) 2014. LEAD INTEGRITY ALERT (LIA) TRIGGERED ON (B)(4) 2014 DUE TO MEETING THE REQUIREMENTS FOR NON SUSTAINED AND VENTRICULAR SIC. THE LIA TRIGGER FOR NON SUSTAINED EVENTS WAS MET ON (B)(4) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RIGHT VENTRICULAR (RV) LEAD INTEGRITY ALERT OCCURRED DUE TO HIGH SHORT INTERVAL COUNTS (SIC) AND NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT) EPISODES. THE ATRIUM LEAD EXHIBITED HIGH THRESHOLDS ALONG WITH RISING THRESHOLDS OF THE LEFT VENTRICULAR (LV) LEAD. DIAGNOSTIC TESTING/TROUBLESHOOTING WAS PERFORMED, AND THE THREE LEADS REMAIN IN USE. SUBSEQUENTLY, THE PATIENT UNDERWENT CARDIAC SURGERY AND REHABILITATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641963 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization| R DTBA2D1 ICD