BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA S

    MDR report key: 2811983 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02394
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 8, 2012
    Report Date
    February 21, 2013
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE DEVICE WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE DEVICE SHOWED NO CAPTURE AND INTERMITTENT CAPTURE. TESTING OF THE LEAD SHOWED THAT THE LEAD WAS WORKING AS EXPECTED. THE DEVICE WAS REMOVED 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 SENSIA S IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. SES01

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other 4092 IMPLANTABLE PACING LEAD