BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1921327 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12460
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 2, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE UPGRADE AFTER PLACING A SUTURE ON THE LEAD THE THRESHOLDS INCREASED, OVER SENSING OCCURRED, AND LEAD IMPEDANCE INCREASED TO GREATER THAN 3000OHMS. THE LEAD WAS CAPPED AND IS NO LONGER IN USE. IT WAS ALSO REPORTED THAT THE NEWLY IMPLANTED LEAD DISLODGED DURING SUTURING THE POCKET. THIS LEAD WAS REPOSITIONED AND IS STILL 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 56 YR Required Intervention 4076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB