BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRAFLEX

    MDR report key: 3993531 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09251
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K790429
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. CONCOMITANT MEDICAL PRODUCTS: A 6957 LEAD IMPLANTED: (B)(6) 1986. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELECTRICAL RESET OCCURRED WITH THE PATIENT'S DEVICE. AT THE DEVICE CHECK, THE RIGHT VENTRICULAR (RV) LEAD SHOWED HIGH IMPEDANCE, NOISE, AND PACING FAILURE. THE RV LEAD WAS PROGRAMMED OFF, AND THE DEVICE'S RESET WAS CLEARED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472175 SPECTRAFLEX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 6957

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention