BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 700 DR

    MDR report key: 1990695 · Received February 15, 2011

    Report

    Report Number
    2647346-2011-00157
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 13, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Removal / Correction Number
    Z-1510/1519-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTERROGATION, THE PATIENT RATE DROPPED TO 30 BEATS PER MINUTE. IT WAS NOTED THAT THE DEVICE HAD TRIGGERED ITS RECOMMENDED REPLACEMENT TIME (RRT) INDICATOR MORE THAN A YEAR PRIOR TO THIS EVENT. 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
    1 KAPPA 700 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KDR701 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R 5568 IMPLANTABLE PACING LEAD| 5054 IMPLANTABLE PACING LEAD