BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3864830 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07491
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 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
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL LEAD 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/SIC (SENSING INTEGRITY COUNTER), AND THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET. THE ANALYST NOTED THAT 161 OF 278 LIFETIME VENTRICULAR SHORT INTERVAL COUNTS (SIC) ARE RECORDED BEGINNING (B)(6) 2013. THE LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED ON (B)(6) 2014 DUE TO MEETING THE REQUIREMENTS FOR NON-SUSTAINED TACHYCARDIA (NST) AND SIC. THERE ARE TWO VENTRICULAR FIBRILLATION (VF) AND 15 NST EVENTS RECORDED ON (B)(6) 2014. 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.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY, AND UPON RETURNING HOME, A LEAD INTEGRITY ALERT (LIA) FOR THE RIGHT VENTRICULAR (RV) LEAD HAD BEEN TRIGGERED ACCORDING TO CARELINK. STORED ELECTOGRAMS SHOWED EVIDENCE OF OVERSENSING LEADING TO SIX INAPPROPRIATE SHOCKS. THE ELECTROGRAMS SHOW WHAT LOOKS LIKE ELECTROMAGNETIC INTERFERENCE. THE PATIENT IS SCHEDULED TO BE SEEN IN ORDER TO INTERROGATE THE DEVICE AND RESET THE ALARM. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338167 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Life Threatening| R D274VRC ICD