BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 6626811 · Received June 8, 2017

    Report

    Report Number
    2649622-2017-06432
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    April 29, 2017
    Report Date
    April 30, 2017
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00681490124799
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: 6949-65 LEAD, IMPLANTED: (B)(6) 2007; 3058 MGU IPG, IMPLANTED: (B)(6) 2015; 3889-28 MGU LEAD, IMPLANTED: (B)(6) 2015; 3058 MGU IPG, IMPLANTED: (B)(6) 2016; 3889-28 MGU LEAD, IMPLANTED: (B)(6) 2016. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED DUE TO OVERSENSING BY THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD HAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR OVERSENSING WITH NOISE, HIGH RATE NON-SUSTAINED EPISODES, SENSING INTEGRITY COUNTER (SIC), AND T-WAVE OVERSENSING (TWOS). THE RV LEAD HAD AN INCREASE IN LEAD IMPEDANCE. THE LEAD WAS FOUND TO HAVE A CONFIRMED FRACTURE. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS SUSPECT OF A FRACTURE. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406755 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45 00681490124799

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R