BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINKLR

    MDR report key: 3992858 · Received August 8, 2014

    Report

    Report Number
    9612164-2014-01049
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE CATHETER INDICATED DAMAGE DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE A PHYSICIAN PERFORMED A TEST FLUSH OF THE IRRIGATION CATHETER AND DID NOT GET FULL IRRIGATION OF ALL HOLES. THE CATHETER WAS TESTED AGAIN WITH SIMILAR RESULTS. THE PHYSICIAN CHOSE TO UTILIZE THE CATHETER DURING THE PROCEDURE WITH NO ADVERSE EVENTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469490 SPRINKLR CARDIAC ABLATION PERCUTANEOUS CATHETER LPB MEDTRONIC MEXICO S17401 207208029

    Patients

    Seq Age Sex Outcome Treatment
    1