BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1924447 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13567
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 THE RIGHT VENTRICULAR LEAD EXPERIENCED NOISE OVERSENSING, POSSIBLY DUE TO LEAD FRACTURE, WHICH LED TO SEVERAL NON-SUSTAINED TACHYCARDIA EPISODES, AND A VENTRICULAR FIBRILLATION EPISODE WITH NON-PHYSIOLOGIC INTERVALS. IT WAS ALSO NOTED THAT THE LEAD INTEGRITY ALERT WAS TRIGGERED, AND THERE WAS AN ELEVATED SHORT INTERVAL COUNT. THE LEAD WAS EXPLANTED AND REPLACED. 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 84 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB