BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2813446 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16757
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 4, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 VERY LOW R WAVES MEASURED ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS CAPPED AND REPLACED. DURING IMPLANTING OF NEW LEAD, THE LEAD WAS DIFFICULT TO PLACE ON SEPTUM DURING INITIAL IMPLANT PROCEDURE. THEN AFTER POCKET WAS SUTURED, LOSSES OF CAPTURE AND HIGH THRESHOLDS WERE SEEN. WHILE VIEWING UNDER FLUOROSCOPY, IT WAS NOTED THAT THE LEAD HAD DISLODGED. A SECOND LEAD WAS OPENED AND ULTIMATELY NOT USED. THE LEAD THAT DISLODGED WAS REPOSITIONED TOWARDS THE RV APEX. THE LEAD REMAINS 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 FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD