BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2790727 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14447
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 8, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVY
    PMA / PMN Number
    P920015/S055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE AND DEFIBRILLATION TESTING THE PHYSICIAN WAS UNABLE TO SUCCESSFULLY TERMINATE VENTRICULAR FIBRILLATION (VF) WITH ANYTHING LESS THAN 35 JOULES. IT WAS ALSO REPORTED THAT REVERSING THE POLARITY AND TURNING OFF THE SUPERIOR VENA CAVA (SVC) COIL WAS UNSUCCESSFUL. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD NVY MEDTRONIC PUERTO RICO, INC. 6947M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R