BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2053358 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05887
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 4, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 RIGHT VENTRICULAR OVERSENSING OCCURRING ON A CHRONIC LEAD THAT WAS JUST CONNECTED TO A NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. USING FLUOROSCOPY, IT WAS NOTED THAT THE LEAD WAS NOT FULLY INSERTED INTO THE CONNECTOR BLOCK. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6945 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB