BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2812893 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17200
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) A PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYSIS FOUND THAT THE OUTER INSULATION HAD A BREACHED DEPRESSION. THE DISTAL CONDUCTOR WAS DISTORTED AND ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE OUTER INSULATION HAD A COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE MEDICAL INSTITUTION AFTER BEING PROMPTED BY A PATIENT ALERT SOUND. THE VENTRICULAR LEAD WAS OVERSENSING WHICH TRIGGERED THE LEAD INTEGRITY ALERT (LIA). IT WAS ALSO NOTED THAT THERE WAS NOISE IN THE ATRIAL CHANNEL AND VARYING ATRIAL IMPEDANCES. THE ATRIAL LEAD REMAINS IN USE AND THE VENTRICULAR LEAD WAS EXPLANTED AND REPLACED. 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 6940

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R D164AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB