BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3991351 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08169
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. THE ANALYST COMMENTED THAT THE DISTAL END OF THE LEAD DID NOT HAVE A BEND OR OTHERWISE IRREGULAR APPEARANCE THAT WAS OBSERVED DURING ANALYSIS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE IMPLANT PROCEDURE IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A BEND NEAR THE DISTAL COIL UPON REMOVAL FROM THE PACKAGE. THE LEAD WAS NOT USED AND ANOTHER 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
    468805 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR A7700E27 HEART VALVE