BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYSTALLINE PASSIVE FIXATION

    MDR report key: 3993764 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09148
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    February 22, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: IMU49JB53 LEAD, IMPLANTED: (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POLARITY SWITCH OCCURRED ON THE RIGHT VENTRICULAR (RV) LEAD FOR HIGH IMPEDANCE. OVERSENSING OF NON-PHYSIOLOGIC INTERVALS WAS NOTED. THE BIPOLAR R-WAVE AMPLITUDE MEASURED AT A HIGH THRESHOLD VALUE. THE UNIPOLAR R-WAVE AMPLITUDE MEASURED LESS THAN BIPOLAR, BUT THE UNIPOLAR AMPLITUDE STILL MEASURED AT A HIGH THRESHOLD VALUE. THE LEAD REMAINS IN USE IN UNIPOLAR CONFIGURATION FOR CONTINUED MONITORING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468030 CRYSTALLINE PASSIVE FIXATION ELECTRODE, PACEMAKER, PERMANENT DTB MPRI ICM09B58

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR ADDR01 IPG