BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2865060 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17646
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    August 24, 2012
    Report Date
    October 26, 2012
    Manufacturer
    MPRI
    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE PROXIMAL CONDUCTOR HAD BLOOD (NOT OBSTRUCTED), THE DISTAL END LOW VOLTAGE ELECTRODE HAD BLOOD AND BODY TISSUE/FIBROTIC GROWTH, THE OUTER INSULATION WAS BREACHED/CUT AND HAD A COSMETIC DEPRESSION, THE INNER INSULATION WAS DISTORTED PULLED/STRETCHED/OVERSTRESSED AND THE LEAD APPEARED TO HAVE EXPLANT DAMAGE. THE ANALYST COMMENTED THAT THE LEAD WAS RETURNED WITH THE HELIX PARTLY EXTENDED, BLOOD AND TISSUE ON IT. BLOOD AND TISSUE ON THE HELIX FROM DISLODGEMENT MOST LIKELY CAUSED THE HELIX TO NOT RETRACT, ALONG WITH THE INNER INSULATION BEING STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS DISLODGED WITHIN APPROXIMATELY TWO MONTHS POST IMPLANT. THE RA 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 MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Hospitalization| R ADDR01 IMPLANTABLE PULSE GENERATOR (IPG)