BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA 300 DR

    MDR report key: 346706 · Received July 11, 2001

    Report

    Report Number
    2647346-2001-00117
    Event Type
    Malfunction
    Date Received
    July 11, 2001
    Date of Event
    April 7, 2001
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    OVERSENSING W/ INTERMITTENT LOSS OF V PACE, SUSPECT LOOSE HEADER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31638 SIGMA 300 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. SDR303 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other 5024M IMPLANTABLE PACING LEAD| 5524M IMPLANTABLE PACING LEAD