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 2018-08-29 for APS? (AUTOMATIC PERIODIC STIMULATION) ELECTRODE 8228052 manufactured by Medtronic Xomed Inc..
[118747591]
Analysis found the yellow c-clip contact was pulled back into the clip body. The contact of the returned sample was 0. 07" away from the inside diameter, which was out of specification. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[118747592]
A health care professional (hcp) reported via a manufacturer representative that the probe had no signal during the thyroidectomy procedure. The procedure was delayed for about five minutes and another probe was used to detect better signals. This was the first time the probe was used. There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2018-00400 |
| MDR Report Key | 7827992 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-08-02 |
| Date Mfgr Received | 2018-08-02 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2018-08-29 |
| 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 | 2018-08-29 |
| Returned To Mfg | 2018-08-24 |
| Model Number | 8228052 |
| Catalog Number | 8228052 |
| Lot Number | 0215570615 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-08-29 |