MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-17 for APS? (AUTOMATIC PERIODIC STIMULATION) ELECTRODE 8228053 manufactured by Medtronic Xomed Inc..
[23218361]
Concomitant products: (1) unknown nim 3. 0 syste; (2) 2mm aps electrode ((b)(4)); 510k: k083124; (b)(4). This device is being reported from a literature review. No devices will be returned, therefore no evaluation could be performed. This device is used for therapeutic purposes.
Patient Sequence No: 1, Text Type: N, H10
[23218362]
From the article published in the "world journal of surgery" on july 3, 2015 entitled "continuous vagal nerve monitoring is dangerous and should not routinely be done during thyroid surgery,�y david j. Terris; katrina chaung; william s. Duke. The article discussed a non-controlled trial of continuous vagal nerve monitoring (cvnm). The study was conducted between february 26, 2014 and june 25, 2014 on 9 non-randomly selected patients undergoing thyroid and parathyroid surgery. In event 2 out of 2 total events (event 1 will be reported on medtronic internal reference number (b)(4)), it was reported that either a 2mm or 3mm aps electrode was used with the medtronic nim 3. 0 system when the aps electrode was "inadvertently and traumatically dislodged, causing vagal neuropraxia" intraoperatively. As a result, there was visible perineural ecchymosis of the vagus nerve and immediate attempts to stimulate both the vagus nerve and right laryngeal nerve were unsuccessful. In the post-anesthesia care unit, the corresponding vocal fold was found to be hypomobile upon flexible laryngoscopy. The nerve dysfunction resolved 1 month postoperatively and there was no report of permanent patient impact or injury as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[101833000]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2015-00275 |
| MDR Report Key | 5009476 |
| Date Received | 2015-08-17 |
| Date of Report | 2015-07-21 |
| Date Mfgr Received | 2015-07-21 |
| Date Added to Maude | 2015-08-17 |
| 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 | JACKLYN HAYMAN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042812769 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| 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 | 0 |
| Brand Name | APS? (AUTOMATIC PERIODIC STIMULATION) ELECTRODE |
| Generic Name | ELECTRODE, NEEDLE |
| Product Code | GXZ |
| Date Received | 2015-08-17 |
| Model Number | 8228053 |
| Catalog Number | 8228053 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Other | 2015-08-17 |