BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2911580 · Received January 11, 2013

    Report

    Report Number
    3007566237-2013-00125
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    July 3, 2012
    Report Date
    December 20, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    KRAKAUER, M., AAKALU, V. K., PUTTERMAN, A. M. TREATMENT OF MALAR FESTOON USING MODIFIED SUBPERIOSTEAL MIDFACE LIFT. OPHTHALMIC PLASTIC AND RECONSTRUCTIVE SURGERY. 2012;28(6):459-462. DOI: 10.1097/IOP.0B013E3182696902. SUMMARY: (B)(6) CAUCASIAN MAN DEVELOPED EXTENSIVE FESTOONS ON BOTH CHEEKS SHORTLY AFTER DEEP BRAIN STIMULATOR SURGERY. THE DESCRIBED SURGICAL TECHNIQUE RESULTED IN SIGNIFICANT REDUCTION IN HIS FESTOONS. THIS APPROACH AVOIDED DIRECT EXCISION OF THE FESTOON AND MADE USE OF A MORE EASILY HIDDEN INCISION. FESTOONS OF THE MIDFACE HAVE BEEN DESCRIBED IN THE LITERATURE, BUT LITTLE DATA EXIST REGARDING THE IDEAL TREATMENT FOR THIS DIFFICULT TO MANAGE PROBLEM. WE REPORT SUCCESSFUL TREATMENT OF FESTOONS WITH A MODIFIED SUBPERIOSTEAL MIDFACE LIFT. REPORTED EVENT: A (B)(6) MALE DEVELOPED SEVERE FACIAL EDEMA THAT RESOLVED SLOWLY FOLLOWING DEEP BRAIN STIMULATOR IMPLANTATION. ON RESOLUTION OF THE EDEMA, THE PATIENT NOTICED OBVIOUS AND DISFIGURING MIDFACIAL FESTOONS. THE PATIENT REPORTED POOR SELF-ESTEEM RELATED TO HIS APPEARANCE AS WELL AS DIFFICULTY WITH NEAR-VISION TASKS DUE TO VISUAL FIELD OBSCURATION ON DOWNGAZE. THE PATIENT UNDERWENT SURGERY TO REDUCE THE FESTOONS. FIVE MONTHS AFTER SURGERY, THE PATIENT EXHIBITED SIGNIFICANT REDUCTION IN THE APPEARANCE OF HIS CHEEK BAGS AND DID NOT EXPERIENCE ANY HYPESTHESIA OR RECURRENCE OF SYMPTOMS. THE PATIENT'S SELF-ESTEEM IMPROVED AND DEPRESSION LESSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16384 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention