MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-03-06 for NVM5 SYSTEM NVM5MULTI manufactured by Nuvasive, Inc..
[39733745]
The patient had a previously-undiagnosed heart dysrhythmia during surgery; the patient and caregivers were unaware of an underlying conduction abnormality. When stimulation was terminated, the dysrhythmia resolved. Review of the device service history indicates no prior functional problems. No malfunction is known to have occurred previously nor in this reported event. Contraindications: comprehensive relative contraindications to use of transcranial motor evoked potential (tcmep) monitoring include epilepsy, cortical lesions, convexity skull defects, raised intracranial pressure, cardiac disease, proconvulsant medications or anesthetics, intracranial electrodes, vascular clips or shunts, and cardiac pacemakers or other implanted biomedical devices. Otherwise unexplained intraoperative seizures and possible arrhythmias are indications to abort tcmep. System was not returned for evaluation
Patient Sequence No: 1, Text Type: N, H10
[39733746]
A (b)(6) year old male underwent a posterior lumbar microdiscectomy at l5-s1. During the closing of the procedure the crna noted apparent presence of extended time between heartbeats, described as both "brief asystole" and "type of heart block". No treatment of the apparent dysrhythmia was reported and surgery continued unaffected. It is not known if the patient had a pre-existing conduction abnormality.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2016-00013 |
| MDR Report Key | 5482775 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-03-06 |
| Date of Report | 2016-03-04 |
| Date of Event | 2016-02-05 |
| Date Added to Maude | 2016-03-06 |
| 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. PAUL HOLBROOK |
| Manufacturer Street | 7475 LUSK BOULEVARD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8583205285 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NVM5 SYSTEM |
| Generic Name | NEUROSURGICAL NERVE LOCATOR |
| Product Code | PDQ |
| Date Received | 2016-03-06 |
| Model Number | NVM5MULTI |
| Operator | PHYSICIAN |
| Device Availability | Y |
| 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 | 2016-03-06 |