BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF DR

    MDR report key: 1830706 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03304
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 1, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE REPORTED FIELD EXPERIENCE OF IMPEDANCE MEASUREMENT ANOMALY WAS VERIFIED. ANALYSIS FOUND THE CASE WIRE TO BE BROKEN INSIDE THE ICD CAN. THE WIRE WAS FRACTURED NEAR THE WELD OF THE ICD CAN. DUE TO THE FRACTURE, THE HIGH VOLTAGE IMPEDANCE WOULD HAVE AFFECTED TWO VECTORS, THE RV TO CAN AND THE SVC TO CAN. NO OTHER ANOMALY WAS DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A COW FELL ON THE PATIENT. SINCE THEN, HIGH IMPEDANCE WAS OBSERVED. AFTER THE PHYSICIAN ELECTED TO EXTRACT THE LEAD, HIGH IMPEDANCE WAS STILL OBSERVED. HENCE, THE ICD WAS REPLACED. DAMAGE TO THE DEVICE'S HEADER WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT RF DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention (B)(4)