BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 6625592 · Received June 8, 2017

    Report

    Report Number
    2649622-2017-05858
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    April 16, 2017
    Report Date
    April 17, 2017
    Manufacturer
    MPRI
    Product Code
    NVY
    UDI-DI
    00643169356627
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED DUE TO OVERSENSING AND SENSING INTEGRITY COUNTER (SIC) AND THERE WAS T-WAVE OVERSENSING (TWOS). IT WAS FURTHER REPORTED THE PATIENT HAS FREQUENT PREMATURE JUNCTIONAL CONTRACTIONS (PJC). THE PATIENT HAS TWOS ON BOTH THE INTRINSIC R WAVE AND THE PJC R WAVE. THE LEAD WAS REPROGRAMMED TIP TO COIL AND THE SENSITIVITY WAS DECREASED. 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
    402636 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62 00643169356627

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention