BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3992326 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09943
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 6, 2014
    Report Date
    August 20, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    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/SIC (SENSING INTEGRITY COUNTER). ANALYSIS ALSO INDICATED THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT, AND THE IMPEDANCE TREND ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS VARIABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: MODEL: 1388T, COMPETITOR LEAD, IMPLANT: (B)(6) 2003-08-15; MODEL: IW1420C75CT, ABDOMINAL STENT GRAFT, IMPLANT: (B)(6) 2008; MODEL: AF2412C170CT, ABDOMINAL STENT GRAFT, IMPLANT: (B)(6) 2008; MODEL: IXW1212C81CT, ABDOMINAL STENT GRAFT, IMPLANT: (B)(6) 2008; MODEL: IW1414C90CT, ABDOMINAL STENT GRAFT IMPLANT: (B)(6) 2008. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS RIGHT VENTRICULAR (RV) LEAD CONTINUES TO EXHIBIT VARIABLE IMPEDANCE AND HIGH SHORT INTERVAL COUNTS (SIC). A PROGRAMMING INTERVENTION HAS BEEN COMPLETED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA). THE LEAD DEMONSTRATED HIGH SHORT INTERVAL COUNTS (SIC), OVERSENSING NOISE, VARIABLE IMPEDANCE LEVELS AND A POTENTIAL FRACTURE IS SUSPECTED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468270 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention