BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA DR

    MDR report key: 3993034 · Received August 8, 2014

    Report

    Report Number
    3008973940-2014-00318
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN FEELING PALPITATIONS AND WENT TO THE HOSPITAL. AN ELECTROCARDIOGRAM WAS DONE AND THEIR HEART RATE WAS 110 BEATS PER MINUTE. THE PATIENT CALLED THE HOTLINE AND IT WAS SUGGESTED THAT THEY GO FOR A DEVICE CHECK AND POSSIBLE REPROGRAMMING. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472730 SENSIA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS SEDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1