BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2864984 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17621
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    August 29, 2012
    Report Date
    October 10, 2012
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015/S055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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 BY THE PATIENT THAT THE RIGHT VENTRICULAR (RV) LEAD WAS REVISED DUE TO BEING DISLODGED WITHIN APPROXIMATELY THREE WEEKS POST IMPLANT. THE RV LEAD WAS REPOSITIONED AND WHEN CHECKED APPROXIMATELY A MONTH AFTER THE REVISION THE THRESHOLD WAS INCREASED. THE RV 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
    1 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD)