BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2814637 · Received November 1, 2012

    Report

    Report Number
    3004209178-2012-09797
    Event Type
    Injury
    Date Received
    November 1, 2012
    Report Date
    September 27, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_STIMLOC_ACC, LOT# VA01996, IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY; PRODUCT ID 3708640, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION; PRODUCT ID 3708640, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V991333, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# VA0199G, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD; PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF STIMLOCK FOUND NO ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD HAD MIGRATED POST-OPERATION. A LEAD REVISION OCCURRED AND THE LEAD WAS REPOSITIONED 2 DAYS AFTER IMPLANTATION. THE LEAD REPOSITIONING WAS A SUCCESS. IT WAS UNCLEAR WHICH IMPLANTABLE NEUROSTIMULATOR (INS) THE LEAD MIGRATION WAS ASSOCIATED WITH. REFER TO MANUFACTURER REPORT # 3004209178-2012-09796.

    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 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention