BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2952529 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00626
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    December 24, 2012
    Report Date
    February 22, 2013
    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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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. ALERTS: 1 -PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012 120:04:36. SENSING/OVERSENSING: 1 - VENTRICULAR NST=140 MS ON (B)(6) 2012 AT 20:03:02. 2-VF<(><<)>=180 MS AVERAGE V-CYCLE ON (B)(6) 2012 AT 20:03:18 AND 20:03:57. A 2-LFP HIGH RATE-NS <(><<)>= 167 MS AVERAGE V-CYCLE ON (B)(6) 2012 AT 20:03:01 AND 20:03:55.

    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).

    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 PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO T-WAVE OVERSENSING (TWOS). FOLLOW UP IS CURRENTLY IN PROGRESS FOR ADDITIONAL INFORMATION. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO T-WAVE OVERSENSING (TWOS). FOLLOW UP IS CURRENTLY IN PROGRESS FOR ADDITIONAL INFORMATION. THE 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
    56207 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Life Threatening (B)(4) IMPLANTABLE DEFIBRILLATOR