BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 4831647 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05441
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    November 25, 2014
    Report Date
    April 25, 2018
    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

    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. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS, HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING ASSOCIATED WITH THE RIGHT VENTRICULAR LEAD. ANALYSIS OF THE DEVICE MEMORY INDICATED THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SENSING INTEGRITY COUNTER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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)(4) 2014, 103 VENTRICULAR SENSING INTEGRITY COUNTS SIC; NO EPISODES AVAILABLE TO VERIFY LEAD NOISE OVERSENSING AND INAPPROPRIATE SHOCKS.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL PORTION OF THE LEAD WAS RETURNED, ANALYZED. ANALYSIS INDICATED THAT THE SETSCREW MARKS ON THE CONNECTOR PIN WERE TOO PROXIMAL. THE ANALYSIS NOTED THAT VISUAL INSPECTION FOUND THAT THERE WAS 1 SET OF SETSCREW MARKS IN CORRECT LOCATION, AND 2 SETS OF SETSCREW MARKS TOO PROXIMAL ON IS-1 PIN. AT THE TIME OF THE LEAD ANALYSIS, IT CANNOT BE DETERMINED WHEN IT HAPPENED. IF THE LEAD IS NOT FULLY INSERTED INTO THE DEVICE, IT MAY CAUSE ELECTRICAL PROBLEM. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE INTERROGATION THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED TO EXHIBIT HIGH SHORT INTERVAL COUNTS (SIC) AND NOISE. NO NON-SUSTAINED TACHYCARDIA EPISODES OR IMPEDANCE DISCREPANCIES WERE NOTED. THE PATIENT WAS HOSPITALIZED, AND PHYSICIAN INDICATED FURTHER DIAGNOSTICS IS STRONGLY RECOMMENDED, BUT LEAD REPLACEMENT IS NOT INDICATED AT THIS TIME. PATIENT SCHEDULED FOR RE-EVALUATION. THE RV LEAD REMAINS IN USE, AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT DURING USE THE RV LEAD EXHIBITED SHORT INTERVALS. THE RV LEAD WAS PARTIALLY EXPLANTED VIA THE PROXIMAL END WAS CUT, LEAD ABANDONED, AND PARTIAL EXPLANT OF REMAINING LEAD. A DIFFERENT LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374164 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R