BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 4925176 · Received July 20, 2015

    Report

    Report Number
    3004209178-2015-13653
    Event Type
    Injury
    Date Received
    July 20, 2015
    Date of Event
    June 30, 2015
    Report Date
    November 22, 2023
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 748266, LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748266, SERIAL# (B)(4) IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7436, SERIAL# (B)(4) IMPLANTED: (B)(6) 2006, EXPLANTED: PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3389S-40, LOT# V012196, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3389-40, LOT# J0546380V, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID 748266 LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748266, SERIAL# (B)(4) IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V012196, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD PRODUCT ID: 3389-40, LOT# J0546380V, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S SYSTEM WAS COMPLETELY REMOVED DUE TO INFECTION. THE IMPLANTABLE NEUROSTIMULATOR (INS) AND EXTENSIONS WERE REMOVED ON (B)(6) 2006 AND THE LEADS WERE REMOVED ON (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469413 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Male Required Intervention "SEE H10...."