BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2810739 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16040
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED TO THEIR PHYSICIAN WITH LIGHT HEADEDNESS, FATIGUE, WEAKNESS, AND NEAR SYNCOPE WITH HEART RATE IN THE UPPER 30'S TO LOW 40'S. IT WAS DETERMINED THERE WAS A COMPLETE CONDUCTOR FRACTURE OF THE RIGHT VENTRICULAR (RV) LEAD WITH HIGH IMPEDANCES. THE LEAD WAS CAPPED AND REPLACED WITH AN EPICARDIAL LEAD DUE TO LEFT SUBCLAVIAN VEIN OCCLUSION AND A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE ON THE RIGHT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4068

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R ADSR01 IMPLANTABLE PULSE GENERATOR