BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA 700 DR

    MDR report key: 1854714 · Received October 5, 2010

    Report

    Report Number
    2647346-2010-00549
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    June 1, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANTED PACEMAKER HAD A MAGNET RATE OF 90 BEATS PER MINUTE AND THAT THE SAME MAGNET RATE HAD BEEN NOTED VIA TRANSTELEPHONIC MONITORING. IT WAS SUBSEQUENTLY REPORTED THAT THIS DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HCP THAT THIS MEDTRONIC PACEMAKER WAS REPLACED DUE TO NORMAL BATTERY DEPLETION ON (B)(6) 2010 AND IT WAS REPLACED WITH A NON-MEDTRONIC DEVICE. THEREFORE, THE (B)(6) 2010 CALL REPORTING THE MAGNET RATE OF 90 BPM COULD NOT REASONABLY HAVE BEEN RELATED TO THE MEDTRONIC (B)(4) DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANTED PACEMAKER HAD A MAGNET RATE OF 90 BEATS PER MINUTE AND THAT THE SAME MAGNET RATE HAD BEEN NOTED VIA TRANSTELEPHONIC MONITORING. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA 700 DR ASKU DXY MEDTRONIC MED REL, INC. KDR701 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other 2X 5076 IMPLANTABLE PACING LEAD| 2X 5076 IMPLANTABLE PACING LEAD