BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4162892 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12551
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 6, 2014
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 THE PATIENT DISPLAYED T WAVE OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD A WEEK AFTER A DEVICE CHANGE OUT. THE OVERSENSING WAS NOTED ON A DEVICE INTERROGATION. THE PHYSICIAN ELECTED TO REOPEN THE POCKET AND INVESTIGATE FURTHER. THE DEVICE WAS NOTED TO HAVE BLOOD IN THE RV LEAD HEADER PORT. THE DEVICE WAS EXPLANTED AND REPLACED AND 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
    639011 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| R DDBB1D4 ICD, 4076-45 LEAD