BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 1921381 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12498
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    August 17, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THE VENTRICULAR LEAD MONITOR ADAPTED TO UNIPOLAR DUE TO LOW IMPEDANCE AND ISSUED A WARNING. THE BIPOLAR IMPEDANCE IS LOWER THAN THE UNIPOLAR IMPEDANCE. SENSING IS BETTER IN BIPOLAR AND CAPTURE IS BETTER IN UNIPOLAR. THE CLINICIAN INDICATED THAT THEY WOULD REPROGRAM THE DEVICE TO BIPOLAR SENSING (AS LONG AS THERE IS NO OVERSENSING/NOISE) AND UNIPOLAR PACING. 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 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4024 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention