BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 900 DR

    MDR report key: 3862614 · Received June 10, 2014

    Report

    Report Number
    2647346-2014-00051
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    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 THE PATIENT FELT SLIGHT UNSTEADINESS WHILE SHOWERING. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT ABLE TO BE INTERROGATED AND A MAGNET RATE WAS NOT ABLE TO BE OBTAINED WITH MAGNET APPLICATION. IT WAS NOTED THAT THE PATIENT HAD MISSED APPOINTMENTS AND THE LAST DEVICE INTERROGATION WAS 22 MONTHS AGO. THE DEVICE 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
    341065 KAPPA 900 DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MDT PUERTO RICO OPERATIONS CO, MED REL KDR901

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| R 5076-58 X2 LEADS