BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST JUDE MEDICAL

    MDR report key: 2578395 · Received May 10, 2012

    Report

    Report Number
    MW5025379
    Event Type
    Injury
    Date Received
    May 10, 2012
    Report Date
    May 10, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DEVICE CLINICIAN IDENTIFIED ISOLATED CHANGES IN THE PACING LEAD IMPEDANCES WHILE REVIEWING REMOTELY TRANSMITTED REPORTS FROM PT'S IMPLANTED CARDIAC DEFIBRILLATOR. THREE ISOLATED LEAD IMPEDANCE MEASUREMENTS APPEARED TO BE LOWER THAN EXPECTED FROM (B)(6) 2011 TO (B)(6) 2012. MENTIONED IMPEDANCES SHOWED AROUND 200 OHMS DECREASE, FROM WHICH CAN BE CONSIDERED BASELINE. FURTHER TESTING REVEALED EXTERNALIZATION OF DEFIBRILLATION WIRE CONDUCTORS BETWEEN PROXIMAL AND DISTAL COILS OF THE RV LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL RIATA LWS ST. JUDE MEDICAL 1580 00243281

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| 1488T/52 ATRIAL LEAD: SERIAL NUMBER: (B)(4)| IMPLANTED:| ST. JUDE MEDICAL| CPI PRIZM II DR 1861 ICD: SERIAL NUMBER: (B)(4)