MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-08-16 for EPLEY OMNIAX B5 NA manufactured by Vesticon, Inc..
[2018880]
A (b)(6), female, with recurrence of bppv underwent right posterior canal repositioning on the omniax using a "li" vibrator. The pt had mild symptoms of vertigo and mild nausea during the repositioning. Nystagmus had resolved after the maneuver. The pt was allowed to sit with the vibrator for an additional 6 minutes in the upright position. When returning to remove her from the chair, she noted onset of right upper chest pain/discomfort. She was cold, clammy and diaphoretic with a normal pulse. She had unlabored breathing and appeared to be concerned but not distressed. After letting her rest for 10-15 minutes, her symptoms had not changed so we put her in a wheelchair and brought her to the er. Initial ekg at the er showed non-specific changes and second ekg a couple hours later was normal. Chest pain resolved shortly after arrival to the er. Troponin level came back elevated. Echo was normal. Angiogram performed the next day was normal and pt was discharged home. Cardiologist stated there was no myocardial infarction and was uncertain as to what happened.
Patient Sequence No: 1, Text Type: D, B5
[9155433]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007625360-2007-00001 |
| MDR Report Key | 2136542 |
| Report Source | 05 |
| Date Received | 2007-08-16 |
| Date of Report | 2007-08-09 |
| Date of Event | 2007-08-07 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2011-06-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 2203 NE OREGON STREET |
| Manufacturer City | PORTLAND OR 97232 |
| Manufacturer Country | US |
| Manufacturer Postal | 97232 |
| Manufacturer Phone | 5032300539 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPLEY OMNIAX |
| Generic Name | NONE |
| Product Code | LXV |
| Date Received | 2007-08-16 |
| Model Number | B5 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VESTICON, INC. |
| Manufacturer Address | PORTLAND OR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2007-08-16 |