BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 2911093 · Received December 31, 2012

    Report

    Report Number
    2911093
    Event Type
    Death
    Date Received
    December 31, 2012
    Date of Event
    December 18, 2012
    Report Date
    December 26, 2012
    Manufacturer
    UNK
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD IMPLANTATION OF A DUAL CHAMBER DEFIBRILLATOR FOR ISCHEMIC CARDIOMYOPATHY IN 2002 AND GENERATOR CHANGE IN 2007. HIS RIGHT VENTRICULAR LEAD HAD BEEN PUT UNDER ADVISORY FOR INCREASED EPISODES OF LEAD FAILURE. THE LEAD WAS EXAMINED UNDER FLUOROSCOPY AND SHOWED EVIDENCE OF INSIDE OUT ABRASIONS OF THE COILS OF THE LEAD. THE PT WAS ALSO EXPERIENCING EPISODES OF LIKELY ABORTED SUDDEN DEATH AND APPROPRIATE SHOCKS FROM HIS DEFIBRILLATOR FOR THE TREATMENT OF VENTRICULAR ARRHYTHMIAS ON MULTIPLE OCCURRENCES. HE WAS SCHEDULED FOR LEAD EXTRACTION ON (B)(6) 2012. HE EXPIRED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL ICD LEAD LWS UNK 1581

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death