BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1050751 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01703
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    March 10, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    NO COMPLAINT WAS RECEIVED WITH THE RETURN OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. ANALYSIS REVEALED OUTER INSULATION ABRASION AT 13.5 CM AND 21 CM FROM THE CONNECTOR. THESE ABRASIONS DID NOT CAUSE THE DAMAGE TO THE RV CABLE INSULATION UNDER THE ABRADED AREAS. THE ABRASION IS CONSISTENT WITH THAT CAUSED BY FRICTION WITH THE ICD CAN. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS 2134265-2010-04345. IT WAS REPORTED THAT FOLLOWING A CAROTID ARTERY TREATMENT PROCEDURE, THE PATIENT EXPERIENCED LOW BLOOD PRESSURE. THE LESION BEING TREATED WAS LOCATED IN THE RIGHT COMMON AND INTERNAL CAROTID ARTERY. THE LESION WAS PRE-DILATED USING AN UNKNOWN BALLOON CATHETER. A FILTERWIRE EZ WAS POSITIONED AND A CAROTID WALLSTENT WAS IMPLANTED. THE LESION WAS PORT-DILATED WITH AN UNKNOWN DEVICE. POST PROCEDURE, 0% STENOSIS WAS NOTED. DURING THE INDEX PROCEDURE, POST STENT DEPLOYMENT, THE PATIENT EXPERIENCED LOW BLOOD PRESSURE, WHICH WAS TREATED WITH A VASOPRESSOR. THE EVENT WAS RESOLVED 5 DAYS POST TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7000/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1