BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECT SECURE

    MDR report key: 2790213 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15003
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 A POSSIBLE CONNECTION ISSUE BETWEEN THE LEAD AND THE DEVICE HEADER. THE PATIENT REPORTED FALLING APPROXIMATELY ONE YEAR AGO. AT THAT TIME THE RIGHT VENTRICULAR (RV) THRESHOLD ROSE TO GREATER THAN 2.5 V AT 0.4 MS, AND HAS BEEN INTERMITTENTLY HIGH SINCE THAT TIME. IT WAS ALSO REPORTED THAT THERE WAS AN INCREASE IN RV PACING IMPEDANCE TO GREATER THAN 2000 OHMS. DURING THE RECENT INTERROGATION THE RV PACING IMPEDANCE WAS GREATER THAN 9,999 OHMS IN UNIPOLAR AND BIPOLAR AND NO CAPTURE AT MAXIMUM OUTPUT. WHEN THE PHYSICIAN REMOVED THE DEVICE FROM THE POCKET IT WAS NOTED THAT THE RV LEAD FELT "LOOSE". AFTER RECONNECTING THE LEAD TO THE EXISTING DEVICE ALL RV MEASUREMENTS WERE WITHIN NORMAL RANGE. BOTH THE LEAD AND DEVICE REMAIN 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 SELECT SECURE IMPLANTABLE PACING LEAD NVN MEDTRONIC PUERTO RICO, INC. 3830

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R 3830 IMPLANTABLE PACING LEAD