MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-11-09 for STRIP/GRID ELECTRODE XXX-AURAGEN manufactured by Integra Neuroscicencs Implants Sa.
[126891282]
It is unknown if the device will be returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation. (b)(4). Https://doi. Org/10. 1016/j. Ebcr. 2017. 12. 001.
Patient Sequence No: 1, Text Type: N, H10
[126891283]
Epilepsy & behavior case reports 9 (2017) published "anterior corpus callosotomy in patients with drug-resistant epilepsy: invasive eeg findings and seizure outcomes" which examined ictal scalp and intracranial electroencephalogram (ieeg) recordings in 16 patients being evaluated for anterior corpus callosotomy (cc) alone or cc in combination with focal resection, to determine the role of the ieeg in predicting postoperative seizure outcomes. It was also examined the distribution of ictal discharges in the rostral? Caudal dimension of the frontal grid electrodes and examined the role of preoperative invasive eeg (ieeg) in establishing lateralization of ictal onset in patients with inconclusive lateralization on non-invasive evaluation. In the treatment approach highlighted in this study, the aim was improve upon the expected palliative effects of cc with the placement of bilateral subdural electrodes as the initial planned stage in a two-step epilepsy surgery. The present series was drawn from all retrospectively identified subjects (age 4 years and above) who received anterior cc or combined cc and resection of the epileptic focus (cc/combined) at the university of nebraska medical center between october 2009 and june 2016. The cc regarded the anterior two-thirds of the corpus callosum in all patients. The patients were included if they were diagnosed with drug resistant epilepsy, underwent comprehensive evaluation with prolonged scalp and invasive video eeg monitoring and had clinical follow-up for more than 9 months. The eeg acquisition was performed using the xltec 7. 1. 1 video-eeg system (natus). The scalp eeg electrodes were placed according to the 10? 20 international system of electrode placement. Platinum invasive electrodes (integra life sciences corporation) were placed unilaterally during craniotomy performed 3? 4 days prior to cc or combined cc and focal resection. The montages for ieeg recordings were comprised of subdural grid and strip electrodes, which were chosen individually based on the information obtained from the surface eeg, imaging and other presurgical tests. The intracranial electrode montages for all participants included right or left frontal grid arrays (64 contacts; 8? 8 array or 32 contacts; 4? 8 array) combined with various combinations of ipsi- or contralateral frontal strip electrodes as well as parietal, temporal, or interhemispheric strip or grid electrodes. In all but one patient the electrodes were placed bilaterally. There were 4? 8 contacts in the strip electrodes, 32? 64 contacts (4? 8 or 8? 8 arrays) in parietal grids, and 20 contacts (4? 5 array) in temporal grids. The interhemispheric grid arrays were comprised of 16 (4? 4), 20 (4? 5), or 32 (4? 8) contacts. Results: there were no deaths in the cohort of patients who met the inclusion criteria. One patient developed a subdural abscess that required drainage. Two patients required treatment in an acute rehabilitation facility for focal weakness after the surgery. One patient developed gait instability, which necessitated treatment in an inpatient rehabilitation facility. Five patients had varying degrees of transient postoperative dysphagia. One required placement of a temporary gastric feeding tube. Five patients had a mild degree of deconditioning and speech difficulties, which improved with outpatient physical, occupational, and speech therapies. Conclusion: from the present data, it was concluded that multistage surgical approaches that involve intracranial eeg recordings prior to cc improves the success of seizure lateralization but does not refine the prediction of postsurgical seizure outcomes in patients with inconclusive scalp eeg. Furthermore, the absence of the organized gradient of seizure discharges in the recordings from frontal grid electrodes suggests that anatomical distribution of these patterns within the frontal cortex has no association with outcomes after cc. As an effective treatment for generalized atonic seizures and focal seizures with impaired awareness, cc should be considered in patients with generalized and multifocal drug-resistant epilepsies. Further data are required before surgical consideration is indicated for patients with other seizure types. In the current series of patients, the benefits of performing combined ieeg in patients considered for cc were not apparent; and therefore further studies involving larger cohorts of patients are needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612007-2018-00033 |
| MDR Report Key | 8057748 |
| Report Source | LITERATURE |
| Date Received | 2018-11-09 |
| Date of Report | 2018-10-18 |
| Date Mfgr Received | 2018-11-12 |
| Date Added to Maude | 2018-11-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA NEUROSCICENCS IMPLANTS SA |
| Manufacturer Street | 2905 ROUTE DES DOLINES |
| Manufacturer City | SOPHIA ANTIPOLIS F-06921 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | F-06921 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRIP/GRID ELECTRODE |
| Generic Name | AURAGEN |
| Product Code | GYC |
| Date Received | 2018-11-09 |
| Catalog Number | XXX-AURAGEN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCICENCS IMPLANTS SA |
| Manufacturer Address | 2905 ROUTE DES DOLINES 2905 ROUTE DES DOLINES SOPHIA ANTIPOLIS F-06921 FR F-06921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-09 |