BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 4376159 · Received December 31, 2014

    Report

    Report Number
    3004209178-2014-24759
    Event Type
    Injury
    Date Received
    December 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    November 19, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3389S-40, LOT # V082874, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL # (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL # (B)(4), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INFECTION OF THE SKIN ON THEIR HEAD IN (B)(6). THE PATIENT HAD SYMPTOMS OF GRANULATION TISSUE ON THE SKIN. THE INFECTION WAS DIAGNOSED IN (B)(6) 2014. A CULTURE WAS TAKEN, BUT IT WAS NEGATIVE WITH NO GROWTH. THE PATIENT¿S HEALTHCARE PROFESSIONAL TREATED THE INFECTION WITH ANTIBIOTICS. THE INFECTION HAD RESOLVED AND THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861197 KINETRA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention