BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2864953 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17545
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015/S055
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD HELIX WOULD NOT DEPLOY ON THE SECOND POSITIONING ATTEMPT.THE LEAD WAS EXPLANTED AND REPLACED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR