BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3013373 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-03997
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    September 12, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708660 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3708660 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3389S-40 LOT# VA03T31, IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3389S-40 LOT# VA03T31, IMPLANTED: 2012 -(B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED WITH AN INFECTION IN THE DEVICE POCKET. THE INFECTION WAS DIAGNOSED THROUGH EXAMINATION AND PALPATION ON (B)(6) 2012 AND SURGICAL OBSERVATION ON (B)(6) 2012. THE DEVICE SYSTEM WAS EXPLANTED ON (B)(6) 2012. IT WAS REPORTED THAT SIGNS AND SYMPTOMS INCLUDED REDNESS, SWELLING, AND FLUID AROUND THE DEVICE AND THE SEVERITY WAS MODERATE. ETIOLOGY WAS NOTED AS A NEW ILLNESS OR CONDITION AND WAS NOT RELATED TO THE DEVICE OR THERAPY AND UNLIKELY RELATED TO THE IMPLANT PROCEDURE. IT WAS NOTED THAT THE EVENT WAS ONGOING AND RESULTED IN IN-PATIENT HOSPITALIZATION. IT WAS REPORTED THAT THE PATIENT WAS "DISCHARGED TO A SKILLED NURSING HOME" ON (B)(6) 2012 FOR ANTIBIOTICS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116489 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R