BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4162434 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12766
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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). LEAD FAILURE PREDICTOR FOR NON-SUSTAINED TACHYCARDIA EPISODES ON (B)(6) 2014, FOR SHORT INTERVAL COUNTS (SIC) ON (B)(6) 2014. LEAD INTEGRITY ALERT (LIA) TRIGGERED (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAD INTEGRITY ALERT (LIA) TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD DUE TO NON-SUSTAINED TACHYCARDIA (NST) EPISODES AND ELEVATED SHORT INTERVAL COUNTS (SIC). NON-PHYSIOLOGIC SENSING WAS NOTED ON ELECTROGRAM. THE LEAD REMAINS IN USE WITH CONSIDERATION FOR A REVISION IN THE NEXT WEEKS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE REPROGRAMMING WAS PERFORMED, BUT OVERSENSING CONTINUED. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639791 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R D334VRG ICD