MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-23 for NIM? EMG ELECTRODE 8227410 manufactured by Medtronic Xomed Inc..
[142770332]
Analysis found that there was a residue consistent with biological contaminants on the device. Visually, there was no external damage to the device. The end to end ohms resistance for the paired electrodes shall be less than 2 ohms with no short circuit between poles; the actual measurements were 1. 6 ohms and 1. 7 ohms respectively, however the ohms resistance between pole read from 100 ohms to 1000 ohms indicating an erratic short circuit. With no physical damage the most probable location for the issue is internally within the overmolded section of the needles at the distal end. There is a number? 51? In the center of the overmold section which typically indicates a mold cavity number. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[142770333]
The health care provider (hcp) reported via manufacturer representative that the electrode was used but no response was observed during the tympanoplasty procedure. There was no intervention planned or performed. There was no delay with the procedure. The procedure was completed with back up electrode and there was a response observed. There was no known patient impact reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2019-00208 |
| MDR Report Key | 8540009 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-23 |
| Date of Report | 2019-10-24 |
| Date of Event | 2019-03-18 |
| Date Mfgr Received | 2019-10-23 |
| Date Added to Maude | 2019-04-23 |
| 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 | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIM? EMG ELECTRODE |
| Generic Name | ELECTRODE, NEEDLE |
| Product Code | GXZ |
| Date Received | 2019-04-23 |
| Returned To Mfg | 2019-04-09 |
| Model Number | 8227410 |
| Catalog Number | 8227410 |
| Lot Number | 0216278612 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-23 |