BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 1925652 · Received December 14, 2010

    Report

    Report Number
    2182208-2010-01003
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    January 1, 2005
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO LEADS HAD SLOWLY DECREASING IMPEDANCES, SINCE THE LAST PACEMAKER CHANGEOUT FIVE YEARS AGO. THE FIRST (B)(4) HAD AN IMPEDANCE OF 203 OHMS AND THE SECOND (B)(4) 209 OHMS. THE LEADS WERE 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
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 7074 IMPLANTABLE PULSE GENERATOR