BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIXNOVUS

    MDR report key: 3073003 · Received April 23, 2013

    Report

    Report Number
    2649622-2013-02717
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    January 3, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    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. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS DISLODGED AND REPOSITIONED ABOUT A MONTH AGO. THE PATIENT WAS SEEN FOR A FOLLOWUP AND THERE WAS NO CAPTURE ON THE LEAD. THE LEAD WAS ALSO UNDERSENSING AND THE PATIENT HAS BEEN EXPERIENCING DIAPHRAGMATIC STIMULATION WITH VENTRICULAR PACING. THE 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
    174761 CAPSUREFIXNOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ADDRL1 IMPLANTABLE IMPLANTABLE PULSE GENERATOR