BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIXNOVUS

    MDR report key: 3071782 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05295
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: ADDR01 IMPLANTABLE PULSE GENERATOR (IPG), IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD A POSSIBLE FRACTURE. THE LEAD EXPERIENCED HIGH IMPEDANCES AND NO SENSING OR CAPTURE. THE LEAD WAS CAPPED 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
    172310 CAPSUREFIXNOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD