BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS LEAD

    MDR report key: 3992785 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09674
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    July 1, 2013
    Report Date
    May 8, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K883743
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    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 MEDICAL PRODUCTS: 5076-52 LEAD, IMPLANTED: (B)(6) 2001. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE ATRIAL PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. ATRIAL LEAD WARNING OCCURRED ON (B)(4) 2014. AUTO LEAD DIAGNOSTICS SHOWS BIPOLAR OPEN CIRCUIT PACES/HIGH IMPEDANCE CONTRIBUTED TO LEAD WARNING; POLARITY SWITCH WITH SUCCESSFUL UNIPOLAR PACES. CHRONIC WEEKLY ATRIAL LEAD IMPEDANCE TREND IS STABLE.

    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 A LEAD WARNING WAS TRIGGERED DUE TO HIGH IMPEDANCES ON THE RIGHT ATRIAL (RA) LEAD. A POLARITY SWITCH OCCURRED AND THE PATIENT EXPERIENCED POCKET STIMULATION AS A RESULT. THE LEAD WAS REPROGRAMMED AND 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
    469003 TRANSVENOUS LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4058M45

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention ADDR01 IPG