BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2964718 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01967
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    December 28, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 DURING A ROUTINE DEVICE CHANGE-OUT PROCEDURE, THE RIGHT ATRIAL LEAD WAS NOTED TO HAVE INTERMITTENT CAPTURE ANDLOW IMPEDANCE. THE RIGHT VENTRICULAR LEAD HAD NO CAPTURE AND LOW IMPEDANCE. BOTH LEADS WERE 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
    68691 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA 4024

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER