BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2801982 · Received October 23, 2012

    Report

    Report Number
    3004209178-2012-09449
    Event Type
    Injury
    Date Received
    October 23, 2012
    Report Date
    September 28, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3387S-40 LOT# V239714, IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3387-40 LOT# V001001, IMPLANTED: 2006 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3387 LOT# V003141, IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ONSET OF THE INFECTION WAS (B)(6) 2012. THE SYMPTOMS WERE LISTED AS REDNESS, SWELLING, DRAINAGE, PAIN, AND THE INCISIONAL WOUND OPENING. THE PRIMARY LOCATION OF THE INFECTION WAS THE "LEAD TRACK." CULTURES TAKEN FROM THE DEVICE POCKET GREW CANDIDA. INTRAVENOUS AND ORAL ANTIBIOTICS, ALONG WITH THE TOTAL DEVICE EXPLANATION, WERE USED FOR TREATMENT OF THE INFECTION. IT WAS NOTED THAT THE PATIENT HAD A PREDISPOSED RISK OF SKIN CANCER. THE PATIENT OUTCOME WAS NOTATED AS "NO DRUG WITHDRAWAL."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED DUE TO INFECTION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention