BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2790343 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14725
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. HOWEVER, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND COSMETIC ENVIRONMENTAL STRESS CRACKING. THE HELIX/LOBE WAS DISTORTED/BENT AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. THERE WAS TISSUE ON THE HELIX AND VISUAL ANALYSIS REVEALED APPARENT EXPLANT DAMAGE. THE LEAD WAS DESTRUCTIVELY ANALYZED TO ATTEMPT TO FIND ANY ANOMALIES RELATED TO THE COMPLAINT. NOTHING WAS OBSERVED IN THE LEAD THAT COULD BE ASSOCIATED WITH THE ELECTRICAL COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD. IT WAS ALSO REPORTED THAT THE RA LEAD HAD LOW SENSING OF P-WAVES. 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. 4076

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD