BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2051223 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05512
    Event Type
    Injury
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    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 THE PATIENT CAME INTO THE CLINIC COMPLAINING OF PALPITATIONS. THERE HAD BEEN A LEAD WARNING, POLARITY SWITCH FROM BIPOLAR TO UNIPOLAR, AND OVERSENSING ON THE RIGHT ATRIAL LEAD. THE LEAD WAS PROGRAMMED BACK TO BIPOLAR, MONITORING ONLY. THE LEAD IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R 5092 IMPLANTABLE PACING LEAD| ADDRS1 IMPLANTABLE PULSE GENERATOR