BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SPRINT FIDELIS ICD LEAD

    MDR report key: 1132774 · Received August 21, 2008

    Report

    Report Number
    MW5008055
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 21, 2008
    Manufacturer
    MEDTRONIC
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WITH BIVENTRICULAR ICD FOR HEART FAILURE. PACEMAKER DEPENDENT. HAD PM PLACED IN 2004, UPGRADED TO BIV ICD IN 2006. RECEIVED MEDTRONIC FIDELIS LEAD. TRANSTELEPHONIC MONITORING OF LEAD IN 2008, DEMONSTRATED NORMAL DEVICE FUNCTION. FOUR DAYS LATER, AFTER REMOVING A SWEATER OVER HIS HEAD, HE FELL TO THE GROUND AND SUFFERED A CARDIAC ARREST. EMTS REPORTED EPISODES OF ASYSTOLE. SUBSEQUENT DEVICE INTERROGATION DEMONSTRATED FINDINGS CONSISTENT WITH RV LEAD FRACTURE -HIGH IMPEDANCE, FAILURE TO PACE-. THE PT WAS RESUSCITATED, PACED VIA HIS LV LEAD, AND INTUBATED. HE SUBSEQUENTLY WAS EXTUBATED AND UNDER WENT SURGICAL LEAD REVISION. INTRA-OPERATIVE TESTING DEMONSTRATED; 1-FRACTURE OF THE DISTAL ELECTRODE - HIGH -IMPEDANCE, FAILURE TO PACE-, WITH INTACT PROXIMAL ELECTRODE, RV COIL, AND SVC COIL, 2-A VISIBLE FRACTURE ON FLUOROSCOPY JUST MEDIAL TO THE RV LEAD ANCHORING SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SPRINT FIDELIS ICD LEAD FIDELIS LWS MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| S