BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 900 DR

    MDR report key: 3861166 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11251
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    February 25, 2014
    Report Date
    April 11, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE PATIENT EXPERIENCED SYMPTOMS DUE TO VVI 65 PROGRAMMING AND DID NOT TOLERATE PACEMAKER SYNDROME WELL. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340108 KAPPA 900 DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC MED REL MEDTRONIC PUERTO RICO KDR901

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R