BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3101056 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-01851
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 2, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. EXTERNAL INSULATION ABRASION WAS FOUND AT 20.6-21.9CM FROM THE CONNECTOR PIN. INSULATION DAMAGE WAS FOUND AT 28.5- 29.9CM FROM THE CONNECTOR PIN, CONSISTENT WITH CLAVICLE CRUSH DAMAGE. THE ETFE COATING WAS INTACT AT THE SAME LOCATION. INTERNAL INSULATION ABRASION WAS FOUND AT 36.0- 36.6CM FROM THE CONNECTOR PIN. THE ETFE COATING WAS ABRADED AT THE SAME LOCATION. THIS IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW UP, ONE EPISODE OF NOISE WITH ABORTED THERAPY WAS OBSERVED ON SESSION RECORDS. THE PHYSICIAN ELECTED TO REPLACE ALL LEADS. DURING EXPLANT, A TEAR OF THE SVC OCCURRED. A THORACOTOMY WAS PERFORMED TO REPAIR THE TEAR. ALL LEADS WERE EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203508 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1582/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention