BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL DX

    MDR report key: 1992425 · Received February 15, 2011

    Report

    Report Number
    6000094-2011-00317
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 1, 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
    NL
    Reporter Occupation
    PHYSICIAN

    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 AND NO ANOMALIES WERE FOUND. THERE WERE TOOL MARKS ON THE CAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN MAGNETIC RESONANCE IMAGING (MRI) SCAN THE PATIENT EXPERIENCED PAIN IN THE AREA OF THE RECORDER IMPLANT. THE DEVICE WAS EXTRACTED. NO PATIENT COMPLICATIONS WERE 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 24 Hospitalization| R