BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF CONTACTR

    MDR report key: 2131072 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10371
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 26, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LPB
    PMA / PMN Number
    P930029/S15
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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 ELECTRODE WAS RETURNED, ANALYZED, AND WAS FOUND TO BE SHORTED.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE ELECTROCARDIOGRAM WAS NOT DISPLAYED BETWEEN THE THIRD AND FOURTH ELECTRODES. CONDUCTOR FRACTURE OF THE FOURTH ELECTRODE WAS SUSPECTED AND CONFIRMED VIA X-RAY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RF CONTACTR ABLATION THERAPEUTIC CATHETER LPB MEDTRONIC PUERTO RICO, INC. 70256034 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other