BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1792432 · Received August 11, 2010

    Report

    Report Number
    2649622-2010-07105
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    May 5, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    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

    REPORT RECEIVED INDICATED THAT T-WAVE OVERSENSING (TWOS) WAS NOTED ON STORED EGM OF EPISODE WHERE SHOCK WAS DELIVERED. THE TWOS WAS SEEN POST BIVENTRICULAR (BIV) PACING, INTERMITTENTLY. THE RIGHT VENTRICLE TIP TO COIL WAS CHECKED AND TWOS PERSISTED. THE DEVICE IS 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention 5076 IMPLANTABLE PACING LEAD| D284DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB