MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-06-16 for BAXANO NEUROLOCALIZATION RIBBON FG0866-02 manufactured by Baxano, Inc..
[16486196]
(b) (4). ( device short). The device was returned for inspection. Electrical short was noticed in the area of the printed circuit board. The manufacturing procedure was revised to include adding a uv adhesive to insulate the printed circuit board face.
Patient Sequence No: 1, Text Type: N, H10
[16703716]
Following a standard decompression at the l4-5 disc level, the physician pulled the neurolocalization ribbon through the left-sided l4 foramen, applied current to localize the nerve root, and achieved desired responses. The physician then attempted to stimulate the nerve out the right-side of the l4 foramen, but no response was achieved when current applied. The device was returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006324586-2009-00008 |
| MDR Report Key | 1471588 |
| Report Source | 05 |
| Date Received | 2009-06-16 |
| Date of Report | 2009-06-16 |
| Date of Event | 2009-05-27 |
| Date Mfgr Received | 2009-05-27 |
| Device Manufacturer Date | 2009-05-01 |
| Date Added to Maude | 2010-03-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | PATTY HEVEY |
| Manufacturer Street | 2660 MARINE WAY, SUITE B |
| Manufacturer City | MOUNTAIN VIEW CA 94043 |
| Manufacturer Country | US |
| Manufacturer Postal | 94043 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAXANO NEUROLOCALIZATION RIBBON |
| Generic Name | NONE |
| Product Code | GZI |
| Date Received | 2009-06-16 |
| Returned To Mfg | 2009-05-29 |
| Catalog Number | FG0866-02 |
| Lot Number | 09050801 |
| Device Expiration Date | 2009-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXANO, INC. |
| Manufacturer Address | 2660 MARINE WAY, SUITE B MOUNTAIN VIEW CA 94043 US 94043 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-16 |