BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5114700 · Received September 30, 2015

    Report

    Report Number
    3007566237-2015-02782
    Event Type
    Injury
    Date Received
    September 30, 2015
    Date of Event
    February 5, 2015
    Report Date
    September 8, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVENT DATE: 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. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION AS THE DBS DEVICE WAS IMPLANTED FOR CHRONIC PAIN. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE LACK OF PAIN RELIEF WAS MISPLACEMENT OF THE ELECTRODES, WHICH WAS VERIFIED VIA MRI SCAN; IT WAS NOTED THAT THERE WAS NO DEVICE FAILURE. THE AUTHOR REPORTED THAT THE SYSTEM HAD BEEN REMOVED TO FACILITATE DTI IMAGING. THE PATIENT IMPROVED AFTER REPLACEMENT OF A NEW DBS SYSTEM.

    Description of Event or Problem · 1

    COENEN, V.A., KIESELBACH, K., MADER, I., REINACHER, P.C. DIFFUSION TENSOR MAGNETIC RESONANCE IMAGING (DTI) TRACTOGRAPHY-GUIDED DEEP BRAIN STIMULATION IN NEUROPATHIC PAIN. ACTA NEUROCHIRURGICA. 2015;157(4):739-741. DOI 10.1007/S00701-015-2356-1. SUMMARY: WE REPORT A PATIENT WHO PRESENTED WITH A NEUROPATHIC TRIGEMINAL PAIN SYNDROME AFTER REPEATED RESECTION OF AN EPIDERMOID TUMOUR INVOLVING THE TRIGEMINAL GANGLION. MULTIPLE THERAPEUTIC APPROACHES-INCLUDING CHRONIC MOTOR CORTEX STIMULATION, INTRATHECAL DRUG APPLICATION AND DEEP BRAIN STIMULATION (DBS) TO THE PERIVENTRICULAR/ PERIAQUEDUCTAL GREY AND SENSORY THALAMUS-DID NOT LEAD TO A SUSTAINED RELIEF OF PAIN REPORTED EVENTS: IT WAS REPORTED THAT THE PATIENT, WHO WAS IMPLANTED WITH DEEP BRAIN STIMULATION (DBS) TO THE PERIVENTRICULAR/PERIAQUEDUCTAL GREY AND SENSORY THALAMUS FOR TREATMENT OF NEUROPATHIC TRIGEMINAL PAIN SYNDROME OCCURRING AFTER REPEATED RESECTION OF AN EPIDERMOID TUMOR INVOLVING THE TRIGEMINAL GANGLION, DID NOT EXPERIENCE A SUSTAINED RELIEF OF PAIN FROM DBS. THE PATIENT HAD A PERSISTENT RATING OF 7-9 ON THE VISUAL ANALOGUE SCALE (VAS). AN MRI SCAN WAS SUSPICIOUS FOR A MALPOSITION OF THE CLINICALLY NON-FUNCTIONAL DBS ELECTRODES. THE DBS SYSTEM WAS COMPLETELY REMOVED SURGICALLY. IT WAS ALSO NOTED THAT DIFFUSION TENSOR MAGNETIC RESONANCE IMAGING (DTI) TRACTOGRAPHY ANALYSIS LATER REVEALED THAT THE PREVIOUSLY MISPLACED ELECTRODES WERE TOUCHING THE MEDIAN POLYSYNAPTIC PAIN SYSTEM. THE SOURCE LITERATURE DID NOT INCLUDE ANY SPECIFIC DEVICE INFORMATION. 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
    645585 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00033 YR Required Intervention