BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 3992597 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09788
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 6, 2014
    Report Date
    August 21, 2018
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 PRODUCTS: 5024M-58 LEAD IMPLANTED: (B)(6) 1995; A7700-27 MECHANICAL HEART VALVE IMPLANTED: (B)(6) 1990.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THERE WAS A DROP OFF IN EXERCISE TOLERANCE. THE EVENT WAS NOTED TO BE RELATED TO THE ATRIAL LEAD. THE EVENT RESOLVED WITHOUT SEQUELAE. THE LEAD WAS NOTED TO BE PART OF THE PRODUCT SURVEILLANCE REGISTRY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NOISE AND OVERSENSING. THE ATRIAL LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468839 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5524M-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R PM2110 COMPETITOR IPG