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 2018-10-23 for APS? (AUTOMATIC PERIODIC STIMULATION) ELECTRODE 8228052 manufactured by Medtronic Xomed Inc..
[124682191]
Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[124682192]
A health care provider (hcp) reported via a manufacturer representative that the electrode did not have any signal during a thyroid procedure. There was no troubleshooting done to resolve the device issue and the procedure was completed using a back-up device. There was no patient impact or injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2018-00530 |
| MDR Report Key | 7994776 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-23 |
| Date of Report | 2018-12-14 |
| Date Mfgr Received | 2018-12-14 |
| Device Manufacturer Date | 2017-07-28 |
| Date Added to Maude | 2018-10-23 |
| 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 | 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 | 2018-10-23 |
| Returned To Mfg | 2018-10-12 |
| Model Number | 8228052 |
| Catalog Number | 8228052 |
| Lot Number | 0213738143 |
| 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 | 2018-10-23 |