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 2019-02-26 for APS? (AUTOMATIC PERIODIC STIMULATION) ELECTRODE 8228052 manufactured by Medtronic Xomed Inc..
[137276530]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[137276531]
A healthcare professional (hcp) reported via a manufacturer representative that when the electrode was placed on the vagus nerve, vigorous movement was observed in the vicinity of vocal cord following pressing the coagulation button of monopolar electrosurgical knife during a thyroid tumor extirpation procedure. The physician requested to confirm if there was current flowing because no movement occurred in case that the button was not pressed. No response was observed although confirmation was made by pressing the button of monopolar electrosurgical knife after removing the electrode. The physician also requested to confirm if injury occurred to the patient's nerve in case of current flowing. The procedure was completed successfully with the device without delay and with no occurrence of paralysis. There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2019-00110 |
| MDR Report Key | 8370881 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-26 |
| Date of Report | 2019-02-26 |
| Date of Event | 2019-01-28 |
| Date Mfgr Received | 2019-01-29 |
| Date Added to Maude | 2019-02-26 |
| 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 | URIZA SHUMS |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328405 |
| 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 | APS? (AUTOMATIC PERIODIC STIMULATION) ELECTRODE |
| Generic Name | ELECTRODE, NEEDLE |
| Product Code | GXZ |
| Date Received | 2019-02-26 |
| Model Number | 8228052 |
| Catalog Number | 8228052 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-02-26 |