BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1925361 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13816
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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) NO ANOMALIES WERE FOUND; THE FULL LEAD WAS RETURNED FOR ANALYSIS. THERE WAS BLOOD/ BODY FLUID ON THE DISTAL AND PROXIMAL CONDUCTORS (NOT OBSTRUCTED). THE INNER INSULATION WAS KINKED BUCKLED. THE OUTER INSULATION HAD A WHITE SUBSTANCE AND A COSMETIC DEPRESSION. THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND SLEEVE HEAD. THE LEAD WAS STRETCHED AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD HAD NO CAPTURE AT MAXIMUM OUTPUT AND THE RIGHT VENTRICULAR LEAD WAS UNDERSENSING. THE RIGHT VENTRICULAR LEAD WAS CAPPED, THE RIGHT ATRIAL LEAD WAS REMOVED AND BOTH WERE 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R 4542 COMPETITOR IMPLANTABLE PACING LEAD| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB