BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2130180 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10127
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION.  BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED IF THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT T-WAVE OVERSENSING (TWOS) HAS RECURRED; WHEN THE HEART RATE GETS HIGH THERE IS T-WAVE OVERSENSING (TWOS) POST SENSE. SENSING WAS REPROGRAMMED FURTHER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS T-WAVE OVERSENSING ON THE RIGHT VENTRICULAR LEAD. THE DEVICE WAS REPROGRAMMED AND THE 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB