BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2813005 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16964
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 9, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S091
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 THERE WAS LOW IMPEDANCE MEASUREMENT AND NO CAPTURE IN THE RIGHT VENTRICULAR LEAD ONE DAY POST IMPLANT. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) COMPETITOR IMPLANTABLE CARDIO/DEFIB