BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 4163261 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12416
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. CONCOMITANT PRODUCT: 4068-45 LEAD, IMPLANTED: (B)(6) 1998. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD RISING AND HIGH THRESHOLDS. THERE WAS ALSO A LEAD WARNING FOR LOW IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED. THE ATRIAL LEAD HAD A LEAD WARNING FOR LOW IMPEDANCE, INTERMITTENT OVERSENSING AND FAR FIELD R-WAVES. THE ATRIAL 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
    643936 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4024-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Hospitalization| R ADDR01 IPG