MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-13 for PAIRED STIMULATING ELECTRODES PSTCUS25026 manufactured by Rhythmlink.
[73020396]
Adverse/allergic reaction to neuro monitoring probes by impulse monitoring. Following neck fusion surgery (c-6, c-7), i had blistering on my arms, legs and head. My feet had an excruciating burn when trying to stand. My entire mouth and throat burned to eat or drink and had a white slippery coating. My tongue was swollen. The muscles in my entire body, (limbs, torso, head) were weak and throbbing in burning pain. It was difficult to walk. I needed help to stay up. My head ached worse than any migraine i ever had. My chest and abdomen felt like it was being torn open when i tried to turn in bed and if i coughed or sneezed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069116 |
| MDR Report Key | 6497108 |
| Date Received | 2017-04-13 |
| Date of Report | 2017-04-13 |
| Date of Event | 2015-12-08 |
| Date Added to Maude | 2017-04-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PAIRED STIMULATING ELECTRODES |
| Generic Name | ELECTRODES |
| Product Code | GXY |
| Date Received | 2017-04-13 |
| Catalog Number | PSTCUS25026 |
| Lot Number | 00003236 |
| Device Expiration Date | 2016-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RHYTHMLINK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Deathisabilit | 2017-04-13 |