BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3860356 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05478
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    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: 4068-52, LEAD, IMPLANTED (B)(6) 2000. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF CHEST PAIN ON EXERTION. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND COULD NOT RULE OUT A MICRO PERFORATION BY THE RIGHT VENTRICULAR (RV) LEAD. UPON LOOKING AT THE LEAD POSITION AND LEAD INTEGRITY, THE PHYSICIAN CHOSE TO EXTRACT THE LEAD AND INSERT A NEW LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343107 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| L| R D314DRM ICD