BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4833181 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-07122
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 22, 2015
    Report Date
    April 24, 2015
    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
    NE, US
    Reporter Occupation
    PHYSICIAN

    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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINE THAT THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED TWO DIFFERENT INAPPROPRIATE SHOCKS DUE TO THE RIGHT VENTRICULAR (RV) LEAD T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE TRIED BUT A SUBSEQUENT CHECK SHOWED MORE NON-SUSTAINED VT EPISODES AS A RESULT OF T-WAVE OVERSENSING. THEREFORE, THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED. THE HIGH VOLTAGE PORTION OF 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
    376306 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| L| R D284DRG ICD, 5076-52 LEAD