BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1991402 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02379
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 1, 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
    IL, 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 AFTER THE PATIENT'S DEVICE WAS CHANGED OUT THAT THE PATIENT PRESENTED WITH SENSING INTEGRITY COUNTS (SIC) AND NON-SUSTAINED TACHYCARDIA EVENTS (NST), THE LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED AND THE LEAD IMPEDANCE HAD SPIKED UPWARDS. POCKET MANIPULATION COULD PRODUCE EGM AND MARKER CHANNEL NOISE. THE LEAD REMAINS IN USE AND A LEAD REVISION IS SCHEDULED. 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 LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R 4568 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB