BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z

    MDR report key: 3992362 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09912
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. PRODUCTS: (B)(4) IPG IMPLANTED: 2006 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHANGEOUT THE RIGHT VENTRICULAR (RV) LEAD APPEARED TO HAVE OUT OF POCKET OVERSENSING, AND IT WAS UNCLEAR IF THE LEAD WAS CAPTURING ADEQUATELY. THE 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
    472249 CAPSURE Z ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5034-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R 5534-53 LEAD