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 8228052 manufactured by Medtronic Xomed Inc..
[23227716]
Concomitant medical products: (1) unknown nim 3. 0 system (unk. Prod. Id/ nim); sn: unknown; manufactured: unknown; 510k: unknown. (b)(4). This device is being reported from a literature review. No devices will be returned, therefore no evaluation could be performed. (b)(4). This device is used for therapeutic purposes.
Patient Sequence No: 1, Text Type: N, H10
[23227717]
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 1 out of 2 total events (event 2 will be reported on medtronic internal reference number (b)(4)), it was reported that a medtronic 2mm aps electrode used with the nim 3. 0 system caused "hemodynamic instability" on a (b)(6) female intraoperatively. Although there were no hemodynamic abnormalities during the process of identification and dissection of the vagus nerve... Shortly after baseline calibration of the aps electrode is when the hemodynamic instability occurred, manifested as bradycardia and hypotension. Hemodynamic stability was promptly reestablished when the aps electrode was removed... Upon a second attempt to establish cvnm, an identical hemodynamic response quickly followed placement of the aps electrode again and reversed promptly when the electrode was removed. As a result, cvnm was abandoned for the remainder of the surgery with no other episodes of hemodynamic instability observed... It was noted that hemodynamic instability was related to the increased parasympathetic tone caused by the vagal stimulation. There was no report of permanent patient impact or injury as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[101832904]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2015-00274 |
| MDR Report Key | 5009477 |
| 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 | 8228052 |
| Catalog Number | 8228052 |
| 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 |