BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 700 DR

    MDR report key: 1922251 · Received December 13, 2010

    Report

    Report Number
    2647346-2010-00831
    Event Type
    Injury
    Date Received
    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
    OH, 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. EVALUATION SUMMARY: (B)(4) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD AN OCCULT DEFECT AND REACHED ELECTIVE REPLACEMENT INDICATORS. THE DEVICE WAS EXPLANTED AND REPLACED. 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 IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KDR701 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R 4068 (X2) IMPLANTABLE PACING LEAD