BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3152475 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06779
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. PRODUCT: 693565 IMPLANTABLE TACHY LEAD, (B)(6) 2013; 419478 IMPLANTABLE PACING LEAD, (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF BACK PAIN POST-IMPLANT. THE PHYSICIAN THOUGHT THERE MIGHT BE A MICRO-PERFORATION OF THE ATRIUM. THE ATRIAL LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253071 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407645

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| L| R D314TRG IMPLANTABLE CRT-D