BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4163021 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12507
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. CONCOMITANT PRODUCT: 4076-52 LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE FOLLOW-UP VISIT THE RIGHT VENTRICULAR (RV) LEAD SHOWED HIGH UNSTABLE THRESHOLD AND THERE MAY HAVE BEEN A POSSIBLE PERFORATION. THE LEAD WAS REVISED AND 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
    639495 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M72

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization| L| R DDBB1D4 ICD