BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 DR PACEMAKER

    MDR report key: 3153761 · Received June 8, 2013

    Report

    Report Number
    9614453-2013-01165
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE ACTUAL PRODUCT WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND ANALYZED THE DATA. THE PRIMARY SAVE TO DISK FINDING NOTED NO ANOMALIES WERE FOUND. CONCOMITANT PRODUCTS: 4064, COMPETITOR IMPLANTABLE PACING LEAD; 4035, COMPETITOR IMPLANTABLE PACING LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SHOWED UNEXPLAINED HIGH VENTRICULAR PACING IN STORED EPISODES. THE PARAMETERS WERE REPROGRAMMED ON THE DEVICE AND IT REMAINS 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
    255283 SIGMA 300 DR PACEMAKER PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC S.A. SDR303U47

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention