BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 1791624 · Received August 10, 2010

    Report

    Report Number
    2649622-2010-06973
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    November 9, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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. PREVIOUS EXPERIENCE FROM A RETRO REVIEW FOR DEVICES STILL IN USE HAS BEEN INCORPORATED INTO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS EXPERIENCING OVERSENSING AND HAD VARYING IMPEDANCE WITH THE IMPEDANCE AT 337 OHMS. THE LEAD POLARITY WAS REPROGRAMMED INITIALLY. IT WAS LATER REPORTED THE IMPEDANCE WAS 200 OHMS. THE LEAD WAS CAPPED AND ABANDONED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS EXPERIENCING OVERSENSING AND HAD ABNORMAL IMPEDANCE. THE LEAD POLARITY WAS REPROGRAMMED. PREVIOUS EXPERIENCE ON THIS DEVICE INCLUDES THE SAME REPORTED INFORMATION. THE LEAD IS STILL IN USE. 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 ASKU DTB MEDTRONIC PUERTO RICO, INC. 4068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R