BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 2882338 · Received December 20, 2012

    Report

    Report Number
    2649622-2012-18290
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 21, 2012
    Report Date
    March 1, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4), THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE DISTAL CONDUCTOR WAS FRACTURED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO A ROUTINE FOLLOW- UP APPOINTMENT "UNWELL AND CRYING" WITH SYMPTOMS RESEMBLING A COLD AND BREATHING DIFFICULTY. THE PATIENT WAS ADMITTED TO THE HOSPITAL WHERE AN XRAY REVEALED A SUSPECTED LEAD FRACTURE. IT WAS FURTHER REPORTED THERE WAS HIGH THRESHOLDS, HIGH IMPEDANCE AND NO SENSING. DURING REPLACEMENT PROCEDURE, LEAD CONDUCTOR SEPARATION WAS VISUALIZED AT PIN END OF LEAD. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO A ROUTINE FOLLOW- UP APPOINTMENT UNWELL AND CRYING, WITH SYMPTOMS RESEMBLING A COLD AND BREATHING DIFFICULTY. THE PATIENT WAS ADMITTED TO THE HOSPITAL WHERE AN X-RAY REVEALED A SUSPECTED LEAD FRACTURE. IT WAS FURTHER REPORTED THERE WAS HIGH THRESHOLDS, HIGH IMPEDANCE AND NO SENSING. DURING REPLACEMENT PROCEDURE, LEAD CONDUCTOR SEPARATION WAS VISUALIZED AT PIN END OF LEAD. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 4965-25

    Patients

    Seq Age Sex Outcome Treatment
    1 00010 MO Hospitalization| R