BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2790611 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14753
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 THE RIGHT VENTRICULAR (RV) LEAD HAD A VENTRICULAR LEAD WARNING THAT WAS LISTED FROM OVER A YEAR AGO. THE LEAD TREND INDICATED HIGH IMPEDANCE. DURING A ROUTINE CHANGE OUT, THE RV LEAD SHOWED INTERMITTENT CAPTURE AND VARYING HIGH IMPEDANCE MEASUREMENTS. THE RV LEAD WAS CAPPED AND REPLACED. DURING THE SAME PROCEDURE, THE ATRIAL LEAD WAS ACCIDENTLY NICKED BY THE PHYSICIAN AND WAS CAPPED AND NOT REPLACED. 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. 5092

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R KDR701 IMPLANTABLE PULSE GENERATOR