BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 200 DR

    MDR report key: 2810431 · Received October 31, 2012

    Report

    Report Number
    2647346-2012-01751
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID NOT FEEL WELL AND THAT REPLACEMENT OF THE PACEMAKER WAS 'LONG OVERDUE." FOLLOW UP WAS UNSUCCESSFUL IN OBTAINING ANY ADDITIONAL PRODUCT PERFORMANCE INFORMATION. THE DEVICE WAS EXPLANTED 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
    1 SIGMA 200 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. SDR203

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD