BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2811814 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17135
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    May 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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 THE PATIENT HAD EPISODES OF T-WAVE OVERSENSING (TWOS) DURING EXERCISE FROM THE RIGHT VENTRICULAR (RV) LEAD. IT WAS ALSO REPORTED THAT REPROGRAMMING WAS DONE FOR SENSITIVITY AND A TREADMILL TEST WAS COMPLETED WHEREBY THE DEVICE WAS SET TO PRE-ER SETTINGS AND AFTER FIVE MINUTES THE TWOS WAS ABLE TO BE REPRODUCED WITH EXERTION. IT WAS DETERMINED THAT SENSING IN TIP TO COIL RESULTED IN NO TWOS. THEREFORE REPROGRAMMING WAS DONE 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
    1 SPRINT QUATTRO SECURE S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention D224DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD