BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3153162 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05839
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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: 406845 IMPLANTABLE PACING LEAD - (B)(6) 2003 ; KDR901 IMPLANTABLE PULSE GENERATOR - (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD NO CAPTURE AT FIVE VOLTS FOR BIPOLAR CONFIGURATION. IT WAS NOTED THAT THE LEAD HAD PREVIOUSLY HAD A CHANGE IN PACING POLARITY TO UNIPOLAR. THE PHYSICIAN ELECTED TO CAP AND REPLACE THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256112 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5068

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R