BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 2954392 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02281
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 28, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 DEVICE: 4023 IMPLANTABLE PACING LEAD (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY REMOTE TRANSMISSION THERE WAS NOISE ON BOTH THE ATRIAL AND VENTRICULAR LEADS WHEN THE STORED DIAGNOSTICS WERE ANALYZED. IT WAS FURTHER DETERMINE THE ATRIAL LEAD ALSO SHOWED OVER SENSING. THE LEADS REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58859 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 452353S

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR ADDR01 IMPLANTABLE PULSE GENERATOR (IPG)