BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINKLR

    MDR report key: 2812309 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03746
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    August 7, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SIMILAR DEVICE TYPE TO A DEVICE MARKETED IN THE U.S. EVALUATION SUMMARY: (B)(6) THE CATHETER WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THAT THE FLUID PATHWAY WAS OCCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN IRRIGATION FAILURE AT THE BEGINNING OF THE PROCEDURE AS THERE WAS WATER PRESENT ON THE SURFACE OF THE CATHETER. THE CATHETER WAS NOT USED AND WAS REPLACED WITH A NEW CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINKLR ABLATION THERAPEUTIC CATHETER LPB MEDTRONIC, INC. S17403

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other