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 2017-05-26 for NUVASIVENVM5 SYSTEM manufactured by Nuvasive, Inc..
[76062552]
No product returned for evaluation. Literature review: "contraindications, the nvm5? System may not be effective, and is not intended for use, when neuromuscular block or epidural blocks have been used for, or in conjunction with, anesthesia. Contraindications to use of transcranial motor evoked potential (mep) monitoring include epilepsy, cortical lesions, convexity skull defects, raised intracranial pressure, cardiac disease, pro-convulsant medications or anesthetics, intracranial electrodes, vascular clips or shunts, and cardiac pacemakers or other implanted biomedical devices. Otherwise unexplained intraoperative seizures and possibly arrhythmias are indications to abort mep. " "contraindication: do not use cutaneous electrodes for stimulation (stimulation electrodes) if the patient has a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock, burns, electrical interference, or death. " "warning: patients with implanted electronic devices, such as cardiac pacemakers, should not be subjected to electrical stimulation unless specialist medical opinion has first been obtained. "
Patient Sequence No: 1, Text Type: N, H10
[76062554]
Received information stating that on (b)(6)2017, patient underwent a discectomy infusion with posterior fixation reportedly with no complications. As per reporter patient expired that night due to acute myocardial infarction. No allegation of product malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2017-00054 |
| MDR Report Key | 6594233 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-26 |
| Date of Report | 2017-05-25 |
| Date of Event | 2017-04-25 |
| Date Mfgr Received | 2017-04-30 |
| Date Added to Maude | 2017-05-26 |
| 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 | MR. DEAN LUCAS |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8586385546 |
| 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 | 2017-05-26 |
| Model Number | NVM5 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Death | 2017-05-26 |