BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT PLUS DR, SJ4 CONNECTOR

    MDR report key: 1831075 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03591
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 28, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. REVIEW OF QUALITY RECORDS. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED NEPHROSTOMY TREATMENT PROCEDURE A GUIDE WIRE SEPARATION OCCURRED. AN UNSPECIFIED NEPHROSTOMY CATHETER WAS IN PLACE. A STAR/JFC/035/150/3J/PTFE/3/10 GUIDE WIRE WAS PLACED THROUGH THE NEPHROSTOMY CATHETER. THE PHYSICIAN PULLED THE WIRE FROM THE BLADDER RETROGRADE THROUGH AND OUT THE URETHRA WITH A SNARE. DURING WITHDRAWAL OF THE WIRE THROUGH THE URETHRA, THE METAL CORE OF THE WIRE DISLODGED FROM THE OUTER SLEEVE OF THE WIRE. THE REMAINING OUTER SLEEVE OF THE WIRE WAS THEN PULLED OUT. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT PLUS DR, SJ4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention 7170Q/58, (B)(4), 1999TC/46, (B)(4)