MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-05-14 for NUVASIVENVM5 SYSTEM manufactured by Nuvasive, Inc..
[108164451]
No product has been returned for evaluation as it remains in-situ. As per reporter no product malfunction was reported to her at the time of procedure nor has in the post-operative phase. No other information has become available. No product malfunction.
Patient Sequence No: 1, Text Type: N, H10
[108164452]
Received information from patient that alleged motor function in her legs has been affected post index surgery. Patient has regained motor function in her left leg, but the right leg is still affected and requires use of a wheelchair for transportation. No allegation of product malfunction has been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2018-00055 |
| MDR Report Key | 7511327 |
| Report Source | CONSUMER |
| Date Received | 2018-05-14 |
| Date of Report | 2018-05-14 |
| Date Mfgr Received | 2018-04-16 |
| Date Added to Maude | 2018-05-14 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. YOBANA SANCHEZ |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8589093383 |
| Manufacturer G1 | NUVASIVE, INC. |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUVASIVENVM5 SYSTEM |
| Generic Name | NEUROSURGICAL NERVE LOCATOR |
| Product Code | PDQ |
| Date Received | 2018-05-14 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE, INC. |
| Manufacturer Address | 7475 LUSK BLVD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-05-14 |