BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 8572572 · Received May 2, 2019

    Report

    Report Number
    2649622-2019-07463
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    April 3, 2019
    Report Date
    May 27, 2019
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: DTBA1Q1, CRTD, IMPLANTED: (B)(6) 2015. 459888, LEAD, IMPLANTED: (B)(6) 2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 INTERMITTENT UNDERSENSING DURING ATRIAL TACHYCARDIA/ ATRIAL FIBRILLATION EPISODES WAS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. DIMINISHED SENSING WAS ALSO NOTED DURING THE EPISODES ON THE RA LEAD. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE RA LEAD WAS REPROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366256 CAPSUREFIX DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694045

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention 6943-65, LEAD.