BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2953485 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01112
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 15, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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: (B)(4), COMPETITOR IMPLANTABLE TACHY LEAD, (B)(6) 2004; 6947, IMPLANTABLE TACHY LEAD, (B)(6) 2004; (B)(4), IMPLANTABLE TACHY LEAD, (B)(6) 2004. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE LEAD SEGMENTS WAS RETURNED TO THE MANUFACTURER AND ANALYZED AND NO ANOMALIES WERE FOUND. THE LEAD DISTAL ELECTRODE WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH AND THE LEAD HAD APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACE/SENSE LEAD DISLODGED POST IMPLANT WITH ELEVATED THRESHOLD. THEREFORE THE LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56457 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407658

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER CARDIO/DEFIB