BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2697517 · Received August 14, 2012

    Report

    Report Number
    3004209178-2012-06889
    Event Type
    Injury
    Date Received
    August 14, 2012
    Date of Event
    August 11, 2011
    Report Date
    July 16, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37642, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37085-95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V080811, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V080811, IMPLANTED: 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT A SURGICAL REVISION OF THE LEAD OCCURRED ON (B)(6)-2012. THE EVENT RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE STILL INCREASED OR HIGH IMPEDANCES ON ELECTRODE 8. THE PATIENT WAS ALSO EXPERIENCING BATTERY DEPLETION. THE PATIENT WAS GOING TO BE SCHEDULED FOR A BATTERY REPLACEMENT SURGERY. IT WAS NOTED THAT ELECTRODE 8 HAD BEEN "REACTIVATED" ON (B)(6) 2012, DURING DEEP BRAIN STIMULATION (DBS) REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCE MEASUREMENT TEST, PERFORMED ON (B)(6) 2011, REVEALED HIGH VALUES ON ELECTRODE 8. IT WAS NOTED THAT THIS EVENT WAS POSSIBLY RELATED TO THE DEVICE OR THERAPY. IT WAS FURTHER NOTED THAT NO INTERVENTION WAS PERFORMED. THE PATIENT OUTCOME WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention