BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2813578 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16541
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 25, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) - THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TWIDDLER'S SYNDROME AND TWIDDLED ALL OF THE LEADS OUT OF PLACE. THE LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED AND REPLACED. BOTH THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS WERE REPOSITIONED AND REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R D314TRM IMPLANTABLE PACEMAKER/CARDIO/DEFIB