BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z

    MDR report key: 2953760 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01294
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    December 6, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH OCCAISIONAL PECTORAL STIMULATION WHEN THE RIGHT VENTRICULAR (RV) LEAD WAS PROGRAMMED UNIPOLAR. THE RV LEAD WAS CAPPED AND REPLACED. THE RIGHT ATRIAL (RA) LEAD IMPEDANCE HAD DECREASED TO LOW MEASUREMENTS. THE RA LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56769 CAPSURE Z ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5034

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)