BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1991780 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02550
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    November 22, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ATRIAL LEAD POLARITY SWITCH, AND THAT THE LEAD EXPERIENCED LOW IMPEDANCE PACES. IN ADDITION, AFTER THE LEAD POLARITY SWITCH, THE LEAD IMPEDANCE DECREASED, AND THERE WERE MANY ATRIAL HIGH RATE/MODE SWITCH EPISODES RECORDED APPARENTLY DUE TO NOISE. THE LEAD POLARITY WAS REPROGRAMMED BACK TO BIPOLAR. IT WAS LATER REPORTED THAT THERE WAS A LEAD WARNING WITH ADDITIONAL LOW IMPEDANCE PACES. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ATRIAL LEAD POLARITY SWITCH, AND THAT THE LEAD EXPERIENCED LOW IMPEDANCE PACES. IN ADDITION, AFTER THE LEAD POLARITY SWITCH, THE LEAD IMPEDANCE DECREASED, AND THERE WERE MANY ATRIAL HIGH RATE/MODE SWITCH EPISODES RECORDED APPARENTLY DUE TO NOISE. THE LEAD POLARITY WAS REPROGRAMMED BACK TO BIPOLAR, AND THE LEAD REMAINS 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 NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4592 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention ADDR01 IMPLANTABLE PULSE GENERATOR| 3830 IMPLANTABLE PACING LEAD| ADDR01 IMPLANTABLE PULSE GENERATOR| 3830 IMPLANTABLE PACING LEAD