BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 900 SR

    MDR report key: 1895231 · Received November 10, 2010

    Report

    Report Number
    6000144-2010-05604
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    April 1, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/014
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    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. DUE TO ADDITIONAL INFORMATION CORRECTED ADVERSE EVENT, EVENT TYPE, PATIENT OUTCOME, EVENT DESCRIPTION, AND DEVICE EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S PARENT THAT AT THE PREVIOUS DAY'S DEVICE CHECK, IT WAS SAID THE LEAD HAD FRACTURED AND THE DEVICE WAS NOT WORKING FOR THE PAST 6 MONTHS. THE LEAD AND DEVICE REMAIN IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S PARENT THAT AT THE PREVIOUS DAY'S DEVICE CHECK, IT WAS SAID THE LEAD HAD FRACTURED AND THE DEVICE WAS NOT WORKING FOR THE PAST 6 MONTHS. THE LEAD WAS CAPPED AND REPLACED AND 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 900 SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KSR901 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization| O| R (B)(4) IMPLANTABLE PULSE GENERATOR