BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA D

    MDR report key: 3862390 · Received June 10, 2014

    Report

    Report Number
    3008973940-2014-00206
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    January 1, 2014
    Report Date
    March 25, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 THREW UP AND FELT LIKE A "SHOCK" ONCE IN THEIR HEART. ABOUT A MONTH LATER, THE PATIENT STARTED TO EXPERIENCE PAIN IN THEIR BACK. THE NEXT MONTH THE PATIENT WAS CHECKED AND THERE WAS NO PACING SIGNAL FROM THE DEVICE. 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
    338104 SENSIA D PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS SED01

    Patients

    Seq Age Sex Outcome Treatment
    1