BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 400 DR

    MDR report key: 1921504 · Received December 13, 2010

    Report

    Report Number
    2647346-2010-00825
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P970012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): BATTERY DEPLETION-NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING SHORTNESS OF BREATH. THE CALLER BELIEVED THE RATE RESPONSE SENSOR WAS TOO AGGRESSIVE. THE DEVICE WAS REPROGRAMMED, AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING SHORTNESS OF BREATH. THE CALLER BELIEVED THE RATE RESPONSE SENSOR WAS TOO AGGRESSIVE. THE DEVICE WAS REPROGRAMMED, AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE DEVICE WAS LATER EXPLANTED AND REPLACED DUE TO ERI (ELECTIVE REPLACEMENT INDICATOR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA 400 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KDR401 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R 5554 IMPLANTABLE PACING LEAD| 5054 IMPLANTABLE PACING LEAD| 5554 IMPLANTABLE PACING LEAD| 5054 IMPLANTABLE PACING LEAD