BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2911015 · Received January 11, 2013

    Report

    Report Number
    3004209178-2013-00479
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    October 5, 2012
    Report Date
    December 18, 2012
    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

    PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PODUCT TYPE EXTENSION, PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3389S-40, LOT# V078937, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3389S-40, LOT# V053074, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED, THERE WAS DISCOMFORT AT THE EXTENSION/LEAD CONNECTION SITE. IT WAS ALSO NOTED, THE ETIOLOGY WAS AT THE INCISIONAL SITE AND DEVICE TRACT. TWO DAYS LATER IT WAS REPORTED, THERE WAS IMPLANT SITE PAIN. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD INCREASING DISCOMFORT FROM THE EXTENSION ATTACHMENT BEHIND THEIR LEFT EAR. WHEN THE AREA WAS PALPATED IT WAS NOTED THERE WAS A HARD SPOT ON THE HEAD WHEN TOUCHED. INTERVENTION INCLUDED REPOSITIONING OF THE EXTENSION. IT WAS NOTED IT WAS RELATED TO THE DEVICE OR THERAPY AND POSSIBLY RELATED TO THE IMPLANT PROCEDURE. EVENT NECESSITATED SURGICAL INTERVENTION. PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16187 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention