MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,study report with the FDA on 2020-03-27 for NEUROBLATE? SYSTEM 20980 NB102 manufactured by Monteris Medical.
[186805437]
It was reported that following an ablation procedure, the patient experienced surrounding edema and midline shift causing mild obstructive hydrocephalus. The event was noted to be possibly related to the neuroblate system and the surgical procedure. The patient was hospitalized from (b)(6) 2020-(b)(6) 2020 with surgical intervention of ventriculostomy. The patient was then discharged and the event was considered resolved as of (b)(6) 2020. There were no further patient complications reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009970070-2020-00030 |
| MDR Report Key | 9889645 |
| Report Source | COMPANY REPRESENTATIVE,STUDY |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2013-06-07 |
| Date Added to Maude | 2020-03-27 |
| 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 | JORDON HONECK |
| Manufacturer Street | 14755 27TH AVE N SUITE C |
| Manufacturer City | PLYMOUTH, MN |
| Manufacturer Country | US |
| Manufacturer G1 | MONTERIS MEDICAL |
| Manufacturer Street | 14755 27TH AVE N SUITE C |
| Manufacturer City | PLYMOUTH, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROBLATE? SYSTEM |
| Generic Name | NEUROBLATE? SYSTEM |
| Product Code | GEX |
| Date Received | 2020-03-27 |
| Model Number | 20980 |
| Catalog Number | NB102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MONTERIS MEDICAL |
| Manufacturer Address | 14755 27TH AVE N SUITE C PLYMOUTH, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-27 |