MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-24 for PAIRED SUBDERMAL ELECTRODE 8227410 manufactured by Medtronic Xomed, Inc..
[181331809]
The nim 3. 0 was being used for a parotid surgery and started to alert at a high frequency. A second nim 3. 0 machine was brought in and all leads were plugged back in and the issue persisted. The disposable red lead on the lower tip was then replaced and the issue was corrected. Possible faulty lead. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5093243 |
MDR Report Key | 9750478 |
Date Received | 2020-02-24 |
Date of Report | 2020-02-20 |
Date of Event | 2020-02-11 |
Date Added to Maude | 2020-02-25 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | RISK MANAGER |
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 | PAIRED SUBDERMAL ELECTRODE |
Generic Name | ELECTRODE, NEEDLE |
Product Code | GXZ |
Date Received | 2020-02-24 |
Catalog Number | 8227410 |
Lot Number | 0219011865 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MEDTRONIC XOMED, INC. |
Manufacturer Address | JACKSONVILLE FL 32216 US 32216 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-02-24 |