BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD

    MDR report key: 5444773 · Received February 18, 2016

    Report

    Report Number
    2938836-2016-01426
    Event Type
    Malfunction
    Date Received
    February 18, 2016
    Report Date
    January 21, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SCV COIL ON DUAL COIL DEFIBRILLATION LEAD EXHIBITED DAMAGED AND OUT OF RANGE LEAD IMPEDANCE. SHOCK CONFIGURATION CHANGED TO RV COIL TO CAN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101164 LEAD LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1