BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 3863205 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06572
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED. THE LEADS ALSO HAD VEGETATION AND A CAPTURE ANOMALY. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339106 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407452

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R ADDRL1 IPG, 407645 LEAD