BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABLEMAPR

    MDR report key: 4160819 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11744
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    June 5, 2014
    Report Date
    July 28, 2014
    Manufacturer
    MPRI
    Product Code
    DRF
    PMA / PMN Number
    K981642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A SUCCESSFUL ABLATION PROCEDURE FOR FLUTTER, THE PATIENT DEVELOPED BRADYCARDIA AND WAS IN NEED OF TEMPORARY PACING. THE PHYSICIAN NOTED THAT THE BRADYCARDIA WAS DUE TO SICK SINUS NODE AFTER ABLATION PROCEDURE. THE PATIENT WAS TREATED WITH INSERTION OF TEMPORARY TRANSVENOUS PACEMAKER. THE CUSTOMER DISCARDED THE CATHETER. THE PATIENT WAS INVOLVED WITH THE MAPPING FOR ACUTE TRANSVENOUS PHRENIC NERVE STIMULATION (B)(6) STUDY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642245 STABLEMAPR CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF MPRI 04402SM FA42103-11

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention 05518SP CABLE