BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL PLUS

    MDR report key: 1853151 · Received September 30, 2010

    Report

    Report Number
    6000144-2010-04275
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    August 28, 2007
    Report Date
    December 5, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    MXC
    PMA / PMN Number
    K994331
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION # (B)(4) FOR A 2 YEAR RETROSPECTIVE REVIEW OF REPORTED EVENTS WHERE THE PRODUCT REMAINED IN USE; DATE RANGE (B)(6) 2008 AND (B)(6) 2010. THIS MEDWATCH REPORT REPRESENTS 1 OF 9 EVENTS (EVENT TYPE CODE SERIOUS INJURY). THIS EVENT OCCURRED OUTSIDE THE US. ALL INFO PROVIDED IS INCLUDED IN THIS REPORT. IF ADD'L RELEVANT INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PT INFO IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER (B)(4) FOR A 2 YEAR RETROSPECTIVE REVIEW OF REPORTED EVENTS WHERE THE PRODUCT REMAINED IN USE; DATE RANGE (B)(6) 2008 AND (B)(6) 2010. THIS MEDWATCH REPORT REPRESENTS 1 OF 9 EVENTS (EVENT TYPE CODE SERIOUS INJURY). 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): (B)(6) - NOT ANALYZED/MET EXPECTED LONGEVITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT FELT WARMTH OVER THE IMPLANTABLE LOOP RECORDER (ILR) DURING AN MRI SCAN. THE MRI SCAN WAS ABORTED. THERE WAS A REPORTED "ROUND AREA OF REDNESS" LOCATED SUPERIOR TO THE TOP OF THE ILR DEVICE, WHICH THE PT INDICATED AN ECG ELECTRODE HAD BEEN PLACED. THE PT ALSO INDICATED THAT SHE DID NOT HAVE THIS REACTION TO THE OTHER TWO SKIN ECG ELECTRODES PLACED ELSEWHERE ON THE BODY. THE PT WAS DISCHARGED HOME AND REPORTED THE SENSATION DISSIPATED AFTER ABOUT AN HOUR. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVEAL PLUS IMPLANTABLE LOOP RECORDER/MXC MXC MEDTRONIC MED REL, INC. 9526 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R