BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2813234 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16735
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 26, 2012
    Report Date
    December 7, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED; ANALYSIS REVEALED NO ANOMALIES. THERE WAS BLOOD ON THE DISTAL ELECTRODE AND ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED.) THE PROXIMAL AND DISTAL CONDUCTORS WERE KINKED/BUCKLED AND THERE WAS A BREACHED CUT ON THE OUTER INSULATION. APPARENT EXPLANT DAMAGE WAS NOTED. (B)(4).

    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 THE RIGHT ATRIAL LEAD HAD A LOSS OF CAPTURE AND INCONSISTENT THRESHOLD. THE 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 NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR