BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREEPI

    MDR report key: 3994035 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02281
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS REVEALED THAT BEGINNING (B)(6) 2014, SENSING INTEGRITY COUNTS INCREASED TO 328. THERE IS THE POTENTIAL FOR LEAD TO LEAD INTERACTION OR INSULATION BREACH. T-WAVE OVERSENSING CANNOT BE CONFIRMED. THE RIGHT VENTRICULAR VLEAD INTEGRITY WARNING OCCURRED (B)(6) 2014 FOR HIGH RATE NON-SUSTAINED EPISODES AND SHORT INTERVAL COUNTER.

    Additional Manufacturer Narrative · 1

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

    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 PRODUCTS: 6721L-50 X2 LEAD, IMPLANTED (B)(6) 2009; 5866-38M ADAPTOR, IMPLANTED (B)(6) 2009; 4965-35 X2 LEAD, IMPLANTED (B)(6) 2009; 4968-35 LEAD, IMPLANTED (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR OVERSENSING OF SHORT INTERVAL COUNTS (SIC) AND NOISE. THE DEVICE CAN TO COIL MORPHOLOGY SHOWED OVER SENSED BEATS CORRESPONDED TO T-WAVE OVERSENSING (TWOS). THE SENSITIVITY WAS DECREASED. THE LEAD REMAINS IN USE WITH CONTINUED FOLLOW-UP. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471795 CAPSUREEPI ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4968-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Required Intervention D314TRG ICD