MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-11 for SENTIO MMG manufactured by Innovative Surgical Solutions.
[16630062]
Minor burn from sentio mmg stimulator noted on pt right buttock from grounding pad when drapes removed. When pt was rolled over on to bed from jackson table a large black necrotic burn noted on pt left anterior thigh. The wire from the sensor that was placed on her thigh had came loose and was touching her left thigh. Surgeon had already left the room when the burns were discovered. He was immediately notified. The sentio mmg stimulator was taken out of service. During the surgery a green light with word go in a circle was noted with words stimulating under it. Then red circle which said stop and not stimulating. The surgeon aware of this during the surgery. New stimulator probe was opened. Stimulator machine turned off then turned back on by stryker spine rep who was troubleshooting the sentio mmg stimulator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043097 |
| MDR Report Key | 4850287 |
| Date Received | 2015-06-11 |
| Date of Report | 2015-06-11 |
| Date of Event | 2015-05-11 |
| Date Added to Maude | 2015-06-17 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SENTIO |
| Generic Name | SENTIO |
| Product Code | PDQ |
| Date Received | 2015-06-11 |
| Model Number | MMG |
| Lot Number | 200013, 200015, 21002, 21003 |
| Device Expiration Date | 2015-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INNOVATIVE SURGICAL SOLUTIONS |
| Manufacturer Address | WIXOM MI 48393 US 48393 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-11 |