MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-06-28 for NICOLET SUBDERMAL NEEDLE * 019-404100 manufactured by Nicolet Biomedical, Inc..
[25680]
On 2/20/96 pt undergoing posterior lumbarspine decompression, fusion and instrumentation had a sterile subdermal recording electrode placed in the left vastus lateralis muscle by the spine fellow. Large amounts of electrical noise prompted the neurophysiology technologist to check the site. The needle had separated from site. The needle had separated from the wire. Needle was visualized on subsequent ap & lateral films. Following completion of the case an unsuccessful attempt was made to remove the needle from the muscle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 35467 |
| MDR Report Key | 35467 |
| Date Received | 1996-06-28 |
| Date of Report | 1996-03-04 |
| Date of Event | 1996-02-20 |
| Date Facility Aware | 1996-02-20 |
| Report Date | 1996-03-04 |
| Date Reported to Mfgr | 1996-03-04 |
| Date Added to Maude | 1996-08-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NICOLET SUBDERMAL NEEDLE |
| Generic Name | SUBDERMAL NEEDLE |
| Product Code | GXE |
| Date Received | 1996-06-28 |
| Model Number | * |
| Catalog Number | 019-404100 |
| Lot Number | * |
| ID Number | 0-4MM, 12 MM LONG |
| Device Expiration Date | 1997-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 36884 |
| Manufacturer | NICOLET BIOMEDICAL, INC. |
| Manufacturer Address | 5225-2 VERONA RD MADISON WI 537114495 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 3 | 1. Other | 1996-06-28 |