BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3993972 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09041
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: ADDR01 IPG, IMPLANTED: (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD EXPERIENCED FLUCTUATING THRESHOLDS. DURING TESTING OF THE LEAD THROUGH THE ANALYZER, SUDDEN LOSS OF CAPTURE WAS NOTED. VARIOUS THRESHOLD MEASUREMENTS WERE SUBSEQUENTLY TESTED, RANGING FROM 1.5 VOLTS AT .50 MS TO 5.0 VOLTS AT .50 MS. ASYSTOLE WAS ALSO NOTED. THE LEAD WAS MANIPULATED BUT LOSS OF CAPTURE WAS NOT REPRODUCED DURING TESTING, ONLY WHEN THE LEAD WAS LEFT ALONE. IT WAS DETERMINED THAT THE LEAD WAS NOT RELIABLE, AND GIVEN THE PATIENT'S PACEMAKER DEPENDENCY, THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470925 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4092-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R 5076-58 LEAD