BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL DX

    MDR report key: 2134001 · Received June 20, 2011

    Report

    Report Number
    6000094-2011-01041
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    July 9, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DSI
    PMA / PMN Number
    K071655
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. 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. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT A "BURNING AND SPARKY" SENSATION IN THE CHEST. THE PATIENT COMPLAINED OF FEELING DIZZY, BEING TIRED, AND HAVING CHEST PAIN. THE PHYSICIAN ATTRIBUTED IT TO POSSIBLE NERVE DAMAGE. THE IMPLANTABLE DIAGNOSTIC MONITOR WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVEAL DX IMPLANTABLE LOOP RECORDER DSI MEDTRONIC S.A. 9528 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R