BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2853138 · Received November 30, 2012

    Report

    Report Number
    3007566237-2012-02879
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    July 12, 2012
    Report Date
    November 4, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD. (B)(4). 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. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IS AN AVERAGE FOR ALL THE PATIENTS.

    Description of Event or Problem · 1

    RUIZ, R. G., CALATAYUD, B. H. SCALP EROSION IN DEEP-BRAIN STIMULATION: A RECONSTRUCTIVE APPROACH. JOURNAL OF PLASTIC AND RECONSTRUCTIVE AESTHETIC SURGERY. 2012; 65(11):1597-1598. DOI: 10.1016/J.BJPS.2012.06.019. SUMMARY: THE AUTHORS HAVE STUDIED A GROUP OF PATIENTS WITH A DBS SYSTEM REFERRED TO OUR UNIT FOR RECONSTRUCTION OF SCALP EROSION WITH STIMULATION DEVICE EXPOSITION. BETWEEN 2005 AND 2009, OVER 20 PATIENTS WERE TREATED, NEARLY HALF OF THEM WITH CLINICAL SIGNS OF INFECTION (ERYTHEMA, OEDEMA AND WARMTH). DEPENDING ON THE CHARACTERISTICS OF THE DEFECT, EITHER A LOCAL ROTATIONAL FLAP OR A FREE FLAP, NAMELY LATISSIMUS DORSI MUSCLE WITH A SPLITTHICKNESS SKIN GRAFT, ANTEROLATERAL THIGH AND RADIAL FASCIOCUTANEOUS FLAP, WAS PERFORMED. IN THIS GROUP OF PATIENTS, A HIGHER RATE OF FLAP FAILURE WAS OBSERVED IN PATIENTS WITH LOCAL FLAPS AND A LATISSIMUS DORSI MUSCLE FREE FLAP WITH SPLIT-THICKNESS SKIN GRAFT WAS USED FOR REPAIR WITHOUT EXPOSURE ON FOLLOW-UP. PATIENTS WHO UNDERWENT A FREE FLAP AS A FIRST OPTION SHOWED A STABLE COVERAGE WITH NO SKIN BREAKDOWN OF WOUND COMPLICATIONS WITH A MINIMUM FOLLOW-UP OF 2 YEARS. IN UNINFECTED PATIENTS, SIMILAR RESULTS WERE OBTAINED. FREE MUSCLE FLAP WITH SKIN GRAFT IS A VERY GOOD OPTION FOR A STABLE SCALP RECONSTRUCTION IN HARDWARE-RELATED SKIN EROSION IN COMPARISON WITH OTHER TREATMENTS THAT ARE TEMPORAL IN MANY CASES. REPORTED EVENTS: 9 PATIENTS SHOWED SIGNS OF INFECTION FOLLOWING IMPLANT. SYMPTOMS INCLUDED ERYTHEMA, EDEMA, AND WARMTH. PATIENTS WERE PRESCRIBED AMOXICILLIN AND CLAVULANIC ACID. PATIENTS WHO RECEIVED A ROTATION-FLAP GRAFT AFTER IMPLANT EXPERIENCED SCALP SKIN EROSION. THE PATIENTS UNDERWENT A FREE FLAP GRAFT AND RECOVERED. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention