BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3990625 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08582
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE STYLET WAS REMOVED FROM THE LEAD WITHOUT DIFFICULTY OR RESISTANCE. THE SAME STYLET WAS USED FOR THE STYLET INSERTION TEST.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE STYLET BECAME STUCK INSIDE THE LEAD. THE LEAD WAS REMOVED, AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468006 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1