BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3900740 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-12223
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-40, LOT# VA05CBS, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# VA05CBS, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS WOUND DRAINAGE AROUND THE SITE OF THE DEEP BRAIN STIMULATOR (DBS) LEAD IMPLANT. IT WAS NOTED THAT THE OUTCOME WAS ONGOING EVENT. IT WAS NOTED THAT THE DIAGNOSTIC METHODS INCLUDED EXAMINATION AND PALPATION. IT WAS NOTED THAT THE RESULTS SHOWED TENDER, RED, AND SWOLLEN ON (B)(6) 2014. IT WAS NOTED THAT THE LAB RESULTS SHOWED THAT WHITE BLOOD COUNT AND C-REACTIVE PROTEIN WERE WITHIN NORMAL LIMITS. IT WAS NOTED THAT THE ETIOLOGY WAS AT THE LEAD AND EXTENSION TRACT. IT WAS NOTED THAT THE EVENT WAS NOT RELATED TO THE DEVICE OR THERAPY. IT WAS NOTED THAT THE EVENT WAS POSSIBLY RELATED TO THE IMPLANT PROCEDURE. IT WAS NOTED THAT SIGNS AND SYMPTOMS INCLUDED RED, SWOLLEN, PAINFUL, AND TENDERNESS. IT WAS NOTED THAT THE EVENT RESULTED IN IN-PATIENT HOSPITALIZATION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE EVENT WAS PROTUBERANCE OF LEADS UNDERLYING SCALP. IT WAS NOTED THAT INTERVENTIONS INCLUDED ORAL ANTIBIOTICS AND IV ANTIBIOTICS. IT WAS NOTED THAT A CT SCAN WITHOUT CONTRAST SHOWED THAT THE DBS ELECTRODES ARE AGAIN SEEN EXTENDING TO THE LEVEL OF THE CEREBRAL PEDUNCLES. IT WAS NOTED THAT THE SCALP SURROUNDING THE EXTRACRANIAL LEADS WAS NORMAL IN APPEARANCE. IT WAS NOTED THAT THE EVENT WAS RELATED TO THE DEVICE OR THERAPY AND WAS POSSIBLY RELATED TO THE IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377214 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization