MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-02 for CUTANEOUS EEG ELECTRODE DCPE-23/B manufactured by Ives Eeg Solutions.
[90874045]
Patient Sequence No: 1, Text Type: N, H10
[90874046]
Patient came to mri on the 3t scanner for a brain, mra head and mra neck exam. When he arrived for the mri he had mri compatible eeg leads on his head. The mri technologist verified the leads were mri compatible by checking the tags at the ends of the leads. About three minutes into the exam, the patient squeezed the emergency ball and stated that it felt as if his neck was burning. The patient was then removed the patient from the mri scanner. The tech noticed that there was a mri compatible lead in the area that the patient stated he felt the burning sensation, which was on the right side of his neck. There was an area of redness on the patient's skin near that lead (mri staff attribute to being from heat, but the eeg manager replicated the redness and attributes to tape). The patient's nurse from the inpatient floor was notified and she stated that it was okay for the mri tech to remove the eeg leads. All the eeg leads were removed in order to allow for the mri to proceed. Once the leads were removed, the techs were able to continue the mri. Mri management was also made aware of the situation. Manufacturer response for ives eeg leads (special package), ives eeg electrode system disposable plastic electrode (per site reporter): ives eeg company was made aware.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6995777 |
| MDR Report Key | 6995777 |
| Date Received | 2017-11-02 |
| Date of Report | 2017-10-26 |
| Date of Event | 2017-10-20 |
| Report Date | 2017-10-24 |
| Date Reported to FDA | 2017-10-24 |
| Date Reported to Mfgr | 2017-10-24 |
| Date Added to Maude | 2017-11-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUTANEOUS EEG ELECTRODE |
| Generic Name | ELECTRODE, CUTANEOUS |
| Product Code | GXY |
| Date Received | 2017-11-02 |
| Returned To Mfg | 2017-10-25 |
| Model Number | DCPE-23/B |
| Catalog Number | DCPE-23/B |
| Lot Number | F2076 |
| ID Number | IDC-001-REV A; IVES EEG LEADS |
| Device Availability | R |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IVES EEG SOLUTIONS |
| Manufacturer Address | 44 MERRIMAC ST NEWBURYPORT MA 01950 US 01950 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-02 |