BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5114270 · Received September 30, 2015

    Report

    Report Number
    3007566237-2015-02775
    Event Type
    Injury
    Date Received
    September 30, 2015
    Date of Event
    August 20, 2015
    Report Date
    September 3, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN GROUP 1 IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN GROUP 1 IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_ UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_ENS_STIMULATOR, PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    MATZKE, C., LINDNER, D., SCHWARZ, J., CLASSEN, J., HAMMER, N., WEISE, D., RUMPF, J-J., FRITZSCH, D., MEIXENSBERGER, J., WINKLER, D. A COMPARISON OF TWO SURGICAL APPROACHES IN FUNCTIONAL NEUROSURGERY: INDIVIDUALIZED VERSUS CONVENTIONAL STEREOTACTIC FRAMES. COMPUTER AIDED SURGERY : OFFICIAL JOURNAL OF THE INTERNATIONAL SOCIETY FOR COMPUTER AIDED SURGERY. 2015:1-7. DOI: 10.3109/10929088.2015.1076042. SUMMARY: THE INDIVIDUALIZED STARFIX_ MINIFRAME BELONGS TO A NEW GENERATION OF STEREOTACTIC SYSTEMS ENABLING HIGH-PRECISION ELECTRODE PLACEMENT WITH CONSIDERABLY BETTER TIME-EFFICIENCY IN DEEP BRAIN STIMULATION (DBS). WE EVALUATED THE USABILITY AND RELIABILITY OF THIS NOVEL TECHNIQUE IN PATIENTS WITH IDIOPATHIC PARKINSON'S DISEASE (IPD) AND COMPARED SURGICAL AND CLINICAL RESULTS WITH THOSE OBTAINED IN A HISTORICAL GROUP IN WHICH A CONVENTIONAL STEREOTACTIC FRAME WAS EMPLOYED. SIXTY PATIENTS UNDERWENT SURGERY FOR IMPLANTATION OF DBS ELECTRODES IN THE SUBTHALAMIC NUCLEUS. IN 31 OF THEM (GROUP I) A CONVENTIONAL ZAMORANO-DUJOVNY FRAME WAS USED AND IN 29 OF THEM (GROUP II) A STARFIX_ MINIFRAME WAS USED. IMAGE FUSION OF PREOPERATIVELY ACQUIRED 3D T1W AND T2W 1.5 T MRIMAGE SERIES WAS USED FOR THE TARGETING PROCEDURE. PLACEMENT OF THE TEST ELECTRODES AND PERMANENT ELECTRODES CORRESPONDED TO STANDARD FUNCTIONAL NEUROSURGERY AND INCLUDED MICROELECTRODE RECORDING AND MACROSTIMULATION. CLINICAL (L-DOPA EQUIVALENT DOSE, UNITED PARKINSON'S DISEASE RATING SCALE PART III) AND TIME FOR SURGICAL ELECTRODE IMPLANTATION WERE EVALUATED POSTOPERATIVELY IN A 3-, 6- AND 12-MONTH FOLLOW-UP. TWELVE MONTHS POSTOPERATIVELY, L-DOPA DOSE WAS SIGNIFICANTLY REDUCED FROM 685.19 TO 205.88 MG/DAY AND FROM 757.92 TO 314.42 MG/DAY IN GROUPS I AND II, RESPECTIVELY. A COMPARABLE REDUCTION OF THE LED COULD BE OBSERVED 1 YEAR AFTER SURGERY. MOTOR FUNCTION HAS IMPROVED IN A SIGNIFICANT AND IDENTICAL MANNER WITH 59% (GROUP I) AND 61% (GROUP II). BESIDES CLINICAL EFFECTS BY STIMULATION THERAPY THERE WAS A SIGNIFICANTLY REDUCED SURGERY TIME REQUIRED FOR ELECTRODE IMPLANTATION USING THE STARFIX_ MINIFRAME (GROUP I: 234.1 MIN, GROUP II: 173.6 MIN; P50.001). INDIVIDUALIZED MINIFRAMES SUCH AS THE STARFIX_ MINIFRAME ALLOW IMPLANTATION OF DBS ELECTRODES IN IPD THAT IS EQUALLY EFFECTIVE AS CONVENTIONAL SYSTEMS. THE TIME EFFICIENCY ACHIEVED IN SURGERY USING OF THE STARFIX_ SYSTEM HELPS TO MINIMIZE PATIENTS' DISCOMFORT DURING DBS SURGERY. REPORTED EVENT IN GROUP 1 (31 PATIENTS, AGE 65, MAJORITY MALE): 1 PATIENT WITH DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE HAD AN INFECTION IN THE AREA OF THE TEMPORARILY EXTERNALIZED ELECTRODE CABLE DURING THE PERIOD OF EXTERNAL TEST STIMULATION. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: LEAD MODEL 3398 AND ACTIVA (MODEL NUMBER NOT GIVEN) IMPLANTABLE NEURO STIMULATOR FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645616 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention