BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3071282 · Received April 22, 2013

    Report

    Report Number
    3007566237-2013-01381
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    HOLLOWAY, K., DOCEF, A. A QUANTITATIVE ASSESSMENT OF THE ACCURACY AND RELIABILITY OF O-ARM IMAGES FOR DEEP BRAIN STIMULATION SURGERY. NEUROSURGERY. 2013;72(-):ONS47-ONS57. DOI: 10.1227/NEU.0B013E318273A090. SUMMARY: 33 DBS SURGERIES WERE PERFORMED UTILIZING THEO-ARM TO IMAGE EACH TRACK WITH DETAILED ANALYSIS OF FIDUCIAL AND TRACK LOCALIZATION ACCURACY. TWENTY-ONE SUBSEQUENT SURGERIES WERE PERFORMED USING O-ARM REGISTRATION. ONLY THE FINAL LEAD POSITION WAS ASSESSED IN THESE INDIVIDUALS. THE MEASUREMENT ERROR OF THE SYSTEM WAS 0.7 MM WITH A MAXIMUM ERROR OF 1.9 MM. 22% OF THE PARALLEL TRACKS THROUGH THE BENGUN EXCEEDED THIS ERROR AND DEMONSTRATED THE ABILITY OF THE O-ARM TO DETECT THESE SKEWED TRACKS. THE ACCURACY OF FINAL LEAD POSITION WAS 2.04 MM IN PROCEDURES WITH REGISTRATION BASED ON AN O-ARM IMAGE. THIS WAS NOT SIGNIFICANTLY DIFFERENT FROM CT-BASED REGISTRATION AT 2.16 MM REPORTED EVENT: THE SIGNIFICANT P VALUE OF THE AP COORDINATE INDICATED THAT THE DBS LEAD IMAGED WITH THE O-ARM WAS SIGNIFICANTLY MORE ANTERIOR THAN THE LEAD IMAGED WITH CT BY 0.18 MM, ALTHOUGH THE MAGNITUDE OF THE DIFFERENCE WAS TOO SMALL TO HAVE CLINICAL SIGNIFICANCE. THERE WERE ALSO INSTANCES OF SLOW DRIFT OF THE LEAD IN SCANS IN A QUANTITY CONSISTENT WITH THE MEASUREMENT ERROR BUT ALL IN THE SAME DIRECTION SO THAT THE FINAL LOCATION ON CT WAS 2 MMS RATHER THAN THE 1 MM DEVIATION EXPECTED. THE CAUSE AND SIGNIFICANCE OF THE DRIFT WAS UNKNOWN. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR THAT REPORTED THE LEAD SHIFTS DID NOT RESULT IN ANY CHANGE OF THERAPY OR ADVERSE EVENTS IN ANY PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172779 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1