BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3142636 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08544
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3387S-40 LOT# VA04SMB, IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3387S-40 LOT# VA04SMB, IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3708660 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3708660 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: CONCOMITANT PRODUCT: PRODUCT ID 3387S-40. THE LEAD LOT # WAS REPORTED AS VA04SMB. THE CORRECT LEAD LOT # SHOULD BE VA045SMB.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT¿S LEAD BACKED OUT AT THE END OF STAGE TWO. THE PATIENT¿S LEAD WAS REPLACED ON (B)(6) 2013, AND THEY RESOLVED WITHOUT SEQUELA. NO PATIENT SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT HAD A CT SCAN WITH CONTRAST ON (B)(6) 2014. IT SHOWED THAT THE RIGHT DEEP BRAIN STIMULATION ELECTRODE ARRAY WAS DISLODGED POSTERIORLY. IT WAS STATED THAT IT WAS RELATED TO THE IMPLANT PROCEDURE AND NOT RELATED TO THE DEVICE OR THERAPY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED ASYMPTOMATIC WHICH OCCURRED AT THE END OF STAGE 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243985 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention