BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 4831345 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05583
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 12, 2015
    Report Date
    March 12, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 WAS EXPERIENCING MANY VENTRICULAR HIGH RATE EVENTS. OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED. IT WAS ALSO REPORTED THAT ATRIAL PACING COULD NOT BE DETECTED DUE TO THE MANAGED VENTRICULAR PACING (MVP) PROGRAMMING PARAMETERS ON THE IMPLANTABLE PULSE GENERATOR (IPG). COMMUNICATION ATTEMPTS WITH THE CLINIC FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. ACCORDING TO MANUFACTURER RECORDS, THE LEAD AND DEVICE 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
    380522 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4092-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR 407645 LEAD, ADDRL1 IPG