MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-24 for RHYTHMLINK RLSND121-1.5 manufactured by Rhythmlink International, Llc.
[83492115]
Patient Sequence No: 1, Text Type: N, H10
[83492116]
Intraoperative monitoring (iom) was used during a spine surgery case. At the end of the procedure, an acquisition needle was removed from behind the left knee. A small dark "pencil tip"-like dot mark was left in the skin where the needle electrode was placed. The small mark did not appear to be from a burn. The needle was found to have some pitting on its surface.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6816368 |
| MDR Report Key | 6816368 |
| Date Received | 2017-08-24 |
| Date of Report | 2017-08-22 |
| Date of Event | 2017-04-27 |
| Report Date | 2017-08-22 |
| Date Reported to FDA | 2017-08-22 |
| Date Reported to Mfgr | 2017-08-22 |
| Date Added to Maude | 2017-08-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RHYTHMLINK |
| Generic Name | ELECTRODE, NEEDLE |
| Product Code | GXZ |
| Date Received | 2017-08-24 |
| Model Number | RLSND121-1.5 |
| Catalog Number | RLSND121-1.5 |
| Lot Number | 00006855 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RHYTHMLINK INTERNATIONAL, LLC |
| Manufacturer Address | 1140 FIRST STREET SOUTH COLUMBIA SC 29209 US 29209 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-24 |