MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-03 for THE WALKAIDE STIMULATOR SYSTEM 20-0100 manufactured by Innovative Neurotronics, Inc..
[21369765]
The device was purchased in 2009. Pt was wearing it initially for 2 hours a day, then prolonged the time of usage to several hours a day (for about a month). At approx two months of usage, the serious hiccups attack occurred, and persisted for several days before we called the emergency exchange - dr. And pt was prescribed chlorpromazine 25 mg 1-2 3 times daily. He was taking the device off for night, when he did, attack slowed a little. He was seen on emergency by the dr. The hiccups persisted besides of medication and pt started to have difficulty breathing. He was seen on emergency by another dr. And was prescribed metoclopramide 10mg 1 tab before night. When he came from appointment with the dr. He took walkaide off permanently and hiccups subsided after a day. Also breathing came back to normal. That visit was one week after the occurrence. We are convinced that this above mentioned device caused those serious events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012419 |
| MDR Report Key | 1441116 |
| Date Received | 2009-08-03 |
| Date Added to Maude | 2009-08-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THE WALKAIDE STIMULATOR SYSTEM |
| Generic Name | WALKAIDE SYSTEM |
| Product Code | GZI |
| Date Received | 2009-08-03 |
| Model Number | 20-0100 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INNOVATIVE NEUROTRONICS, INC. |
| Manufacturer Address | 3600 N CAPITAL OF TEXAS HGWY BLD B STE 150 AUSTIN TX 78746321 US 78746 3211 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-08-03 |