BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4551755 · Received February 26, 2015

    Report

    Report Number
    3007566237-2015-00468
    Event Type
    Injury
    Date Received
    February 26, 2015
    Report Date
    February 2, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389S, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE: EXTENSION; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE: EXTENSION; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE: EXTENSION; PRODUCT ID 3389S, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    MATZKE, C., HAMMER, N., WEISE, D., LINDNER, D., FRITZSCH, D., CLASSEN, J., MELXENSBERGER, J., WINKLER, D. DEEP BRAIN STIMULATION USING SIMULTANEOUS STEREOTACTIC ELECTRODE PLACEMENT : AN ALTERNATIVE TO CONVENTIONAL FUNCTIONAL STEREOTAXY? DER NERVENARZT. 2014. DOI: 10.1007/S00115-014-4214-4. SUMMARY: THE SUBTHALAMIC NUCLEUS REGION (STN) IS UNDOUBTEDLY ONE OF THE MOST PREFERRED TARGET REGIONS FOR THE STIMULATIVE TREATMENT OF IDIOPATHIC PARKINSON¿S DISEASE (IPD). IN ADDITION TO PRE-OPERATIVE IMAGING AND SECONDARY IMAGE PROCESSING, ACTUAL ELECTRODE PLACEMENT IS THE SUBJECT OF PRESENT DISCUSSIONS. HERE, THE STEREOTACTIC PRINCIPLE IS THE KEY TO SUCCESS. AN ENTIRELY NEW APPROACH AND, IN ITS IMPORTANCE NOT PREVIOUSLY APPRECIATED ONE, IS THAT OF AN INDIVIDUALIZED AND SEMI-AUTOMATED PROCEDURE FOR THE STEREOTACTIC CARE OF PATIENTS. THE SYSTEM PRESENTED IN THIS STUDY OFFERS THE OPPORTUNITY FOR THE FIRST TIME TO DISCUSS AN INDIVIDUALIZED PROCEDURE IN THE CONTEXT OF FUNCTIONAL STEREOTAXY. THE BASIS AND AT THE SAME TIME LIMITATION OF THE CONVENTIONAL STEREOTACTIC SYSTEMS USED HITHERTO IS THEIR RIGID STRUCTURE IN TERMS OF INFLEXIBLE RING SYSTEMS FIXED TO THE PATIENTS¿ HEAD. REPORTED EVENTS: 1. ONE PATIENT WITH BILATERAL DEEP BRAIN STIMULATION (DBS) FOR PARKINSON¿S DISEASE HAD AN INFECTION IN THE GENERATOR POCKET. IT WAS NOTED THAT THIS COMPLICATION WAS CONSERVATIVELY TREATED. 2. ONE PATIENT WITH BILATERAL DEEP BRAIN STIMULATION (DBS) FOR PARKINSON¿S DISEASE HAD AN INFECTION IN A BONE ANCHOR PLACED IN THE ANTERIOR AREA. IT WAS NOTED THAT THIS COMPLICATION WAS CONSERVATIVELY TREATED. 3. ONE PATIENT WITH BILATERAL DEEP BRAIN STIMULATION (DBS) FOR PARKINSON¿S DISEASE EXPERIENCED AN ELECTRODE BREAK. THIS DEFECT REPORTEDLY LED TO ELECTRIFYING SENSATIONS IN THE HEAD REGION AND A NEED FOR REVISION. 4. ONE PATIENT WITH BILATERAL DEEP BRAIN STIMULATION (DBS) FOR PARKINSON¿S DISEASE EXPERIENCED AN INFECTION IN THE TEMPORARILY EXTERNALIZED ELECTRODE CABLE DURING THE TEST PHASE. 5. ONE PATIENT WITH BILATERAL DEEP BRAIN STIMULATION (DBS) FOR PARKINSON¿S DISEASE EXPERIENCED A BALLOONING OF THE GENERATOR POCKET REQUIRING REVISION AS A RESULT OF A COLLECTION OF CEREBRAL SPINAL FLUID (CSF). THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: QUADRIPOLAR PLATINUM/IRIDIUM ELECTRODE MODEL 3398 AND ACTIVA IMPLANTABLE NEUROSTIMULATOR UNKNOWN MODEL NUMBER 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
    135748 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention