BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 4160758 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11756
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCT: 559453 LEAD, (B)(6) 2012. (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 DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. 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/SIC (SENSING INTEGRITY COUNTER). 1110 OF 1112 LIFETIME V-SIC ARE RECORDED BEGINNING (B)(6) 2014. LIA TRIGGERED ON (B)(6) 2014 DUE TO MEETING THE REQUIREMENTS FOR IMPEDANCE AND V-SIC. MAX V PACE IMPEDANCE RISES FROM 703 OHM THE WEEK ENDING (B)(6) 2014 TO 1767 OHM THE WEEK ENDING (B)(6) 2014. THERE ARE 15 NON-SUSTAINED EVENTS OF LESS THAN 220 MILLISECONDS (MS) V-V CYCLE RECORDED ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL BECAUSE THEIR ALARM WENT OFF. A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED DUE TO HIGH IMPEDANCE, INCREASED SENSING INTEGRITY COUNT (SIC), AND SHORT AND FAST NON-SUSTAINED (NST) EPISODES ON THE RIGHT VENTRICULAR LEAD. LEAD FRACTURE IS SUSPECTED. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641736 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-75

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization| R D294DRG ICD