BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRICULAR LEAD

    MDR report key: 2211329 · Received August 3, 2011

    Report

    Report Number
    2211329
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    July 16, 2011
    Report Date
    August 2, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    (B)(6) MALE WITH HISTORY OF CAD (CORONARY ARTERY DISEASE), REMOTE MI IN 1989 AND CARDIOMYOPATHY. THE PATIENT WAS ADMITTED DUE TO COMPLAINTS OF RECURRENT DEFIBRILLATOR SHOCKS, WHICH HAD BEEN SECONDARY TO OVER SENSING IN THE VENTRICULAR LEAD FOR CLEAR VENTRICULAR LEAD FRACTURE AS PER CARDIOLOGIST. THE PATIENT SCHEDULED FOR GENERATOR REPLACEMENT, RV DEFIB LEAD REPLACEMENT AND ATRIAL LEAD PLACEMENT. ADDENDUM: UNSURE OF LEAD PLACEMENT DATE, HOWEVER PER MEDICAL RECORD THE DEFIBRILLATOR HAD BEEN IMPLANTED IN 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRICULAR LEAD VENTRICULAR LEAD LWS MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R