BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2791053 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15092
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 TRIGGERED A PATIENT ALERT FOR OVERSENSING. THE LEAD WAS DETERMINED TO BE FRACTURED. THE PHYSICIAN THOUGHT THE FRACTURE WAS DUE TO COMPRESSION OF THE LEAD WHILE THE PATIENT WAS USING CRUTCHES. THE LEAD WAS PROGRAMMED OFF AND THE PATIENT WAS PROVIDED WITH A LIFEVEST. A LEAD REPLACEMENT WILL BE SCHEDULED ONCE THE PATIENT IS AMBULATORY WITHOUT CRUTCHES. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| D284DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB