BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 3021233 · Received March 24, 2013

    Report

    Report Number
    3021233
    Event Type
    Malfunction
    Date Received
    March 24, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 23, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S RV LEAD WAS REMOVED DUE TO LEAD FRACTURES AND THE PATIENT RECEIVED A NEW ICD. THE LEADS WERE DETACHED FROM THE PULSE GENERATOR AND THE RV LEAD WAS EXTRACTED USING 1) A LOCKING STYLET AND 2) A LASER SHEATH WITHOUT ANY COMPLICATIONS. RA LEAD PARAMETERS REMAINED STABLE. A WIRE WAS EXCHANGED THROUGH THE LASER SHEATH AND USED FOR PLACEMENT OF A NEW RV LEAD, VIA A 9FR SHEATH, USING ACTIVE FIXATION IN THE RV APEX. EXCELLENT LEAD PARAMETERS WERE OBTAINED. A 2ND 9FR SHEATH WAS ALSO USED TO ACCESS THE AXILLARY VEIN AND DESPITE CONSIDERABLE EFFORT, WE COULD NOT PLACE A LV LEAD DUE TO EXTREMELY TORTUOUS CS OS. THE FINAL SHEATH WAS REMOVED AND PRESSURE HELD UNTIL HEMOSTASIS. THE POCKET WAS COPIOUSLY IRRIGATED WITH NORMAL SALINE CONTAINING GENTAMICIN AND SUBSEQUENTLY OBSERVED. THE NEW GENERATOR WAS CONNECTED TO THE RA AND RV LEAD WITH STABLE AND ADEQUATE LEAD PARAMATERS. ONCE ADEQUATE HEMOSTASIS WAS CONFIRMED, THE POCKET WAS CLOSED IN THREE LAYERS WITH 0 VICRYL INTERRUPTED, 2-0 VICRYL INTERRUPTED, 3-0 VICRYL CONTINUOUS AND 4-0 PDS CONTINUOUS. THIS WAS FOLLOWED BY INDERMIL AND TELF AND TEGADERM. RIGHT FEMORAL SHEATHS THEN REMOVED AND PRESSURE HELD UNTIL HEMOSTASIS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LEAD EXTRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121073 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARD LWS MEDTRONIC, INC. 6948 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR