BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2051726 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05642
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    January 27, 2011
    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
    WA, 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) THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES FOUND. THERE WAS APPARENT EXPLANT DAMAGE. THE PROXIMAL CONDUCTOR WAS DISTORTED AND HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE OUTER INSULATION HAD A BREACHED CUT. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD DISLODGED POST-IMPLANT. DURING THE REPOSITIONING ATTEMPT THE LEAD KINKED DUE TO DIFFICULT PATIENT ANATOMY. 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR