BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2951922 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00294
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 8, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: 5068, IMPLANTABLE PACING LEAD, (B)(6) 1999. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD DEVELOPED HIGH THRESHOLDS OVER TIME AND APPEARED TO HAVE SIGNS OF CLAVICLE CRUSH. 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
    56099 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5068-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR ADDR01 IMPLANTABLE PULSE GENERATOR