BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE RF

    MDR report key: 1223211 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03715
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 6, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND THAT THE DEVICE EXHIBITED HIGH IMPEDANCE, DUE TO AN INTERNAL SHORT CIRCUIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HV LEAD IMPEDANCE WAS OUT OF RANGE FOR THE SVC TO CAN MEASUREMENT. THE OUT OF RANGE MEASURE- MENTS OCCURRED OUT OF CLINIC. THE PHYSICIAN OPENED THE POCKET TO DETERMINE THE CAUSE OF THE HIGH IMPEDANCE. THE DEVICE AND RV LEAD WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMOTE RF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 3207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention