BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 1111554 · Received August 13, 2008

    Report

    Report Number
    3004209178-2008-04909
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    October 1, 2007
    Report Date
    July 16, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER DEEP BRAIN STIMULATOR IMPLANT THE PATIENT HAD GOOD OUTCOMES ON 1 SIDE AND NOT ON THE OTHER. THERE WERE HIGH IMPEDANCES AND A LOSS OF THERAPY ON ONE SIDE. THE HCP WAS UNABLE TO DETERMINE THE CAUSE OF THE HIGH IMPEDANCES. THE DEEP BRAIN STIMULATOR WAS REPLACED. ULTIMATELY THE ENTIRE SYSTEM WAS EXPLANTED DUE TO INFECTION (REF. MANUFACTURER'S REPORT# 3004209178-2008-00167 AND 2082207-2008-00168). A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention EXPLANTED| LEAD MODEL LEAD LOT# UNK| EXPLANTED| EXTENSION MODEL 7482 LOT# NHU160487V| EXPLANTED| LEAD MODEL LEAD LOT# UNK| EXPLANTED| IMPLANTED| EXTENSION MODEL 7482 LOT# NHU160488V| IMPLANTED| IMPLANTED| IMPLANTED