BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z

    MDR report key: 3991038 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08361
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD WARNING A HIGH SHORT INTERVAL COUNTS (SIC) COUNT AND RISING IMPEDANCE. A LOOSE CONNECTION WAS SUSPECTED. THE LEAD WAS INITIALLY PROGRAMMED TO UNIPOLAR MODE FOR CONTINUED USE AND MONITORING. SUBSEQUENTLY, A CHEST X-RAY WAS PERFORMED WHICH REVEALED THE POTENTIAL OF A LOOSE SET-SCREW AT THE DEVICE CONNECTION. A REVISION PROCEDURE WAS PERFORMED TO DISCONNECT AND RECONNECT THE LEAD TO THE DEVICE. THE ISSUE WAS RESOLVED. THE DEVICE AND THE LEAD 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
    471757 CAPSURE Z ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5034-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00095 YR Hospitalization| R ADSR01 IPG