BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA 300 D

    MDR report key: 1922725 · Received December 13, 2010

    Report

    Report Number
    2647346-2010-00838
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 14, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO CAPTURE IN THE ATRIUM. PHYSICIAN NOT ENTIRELY CLEAR IF ISSUE WAS DEVICE OR LEAD RELATED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 D IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. SD303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other