BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 600 DR

    MDR report key: 1861657 · Received October 8, 2010

    Report

    Report Number
    2647346-2010-00590
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    May 1, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S9
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT FEELING WELL AND THAT HALF OF THE DEVICE WAS NOT WORKING. THE DEVICE TRIPPED ELECTIVE REPLACEMENT INDICATORS AND WHEN THE DEVICE DOES THIS IT SWITCHES TO VVI MODE WHICH WOULD EXPLAIN WHY HALF THE DEVICE STOPPED WORKING (PER A SYSTEMS ENGINEER). 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
    1 KAPPA 600 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KDR653 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention 4568 IMPLANTABLE PACING LEAD| 4092 IMPLANTABLE PACING LEAD