MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-27 for ELECTROPHYSIOLOGICAL MACHINE CA2000 N/A manufactured by Nicolet.
[18480720]
During surgical placement of instrumentation (1) mfr: danek/tsrh rod and (2) mfr: stuart/catrell dc plates in the spinal area, e. P. Machine experienced a loss of signal. Subsequently, patient was awakened to test neurological response. Found lower bilateral legs compromised. Hardware removed. Continued loss of sensation bilateral lower limbsdevice not labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Device not serviced in accordance with service schedule. Date last serviced: 01-feb-92. Service provided by: manufacturer. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device temporarily removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4012 |
| MDR Report Key | 4012 |
| Date Received | 1992-07-27 |
| Date of Report | 1992-05-28 |
| Date of Event | 1992-04-23 |
| Date Facility Aware | 1992-05-02 |
| Report Date | 1992-05-28 |
| Date Reported to Mfgr | 1992-05-28 |
| Date Added to Maude | 1993-05-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECTROPHYSIOLOGICAL MACHINE |
| Generic Name | EVOKE POTENTIAL MONITOR |
| Product Code | GYE |
| Date Received | 1992-07-27 |
| Model Number | CA2000 |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01-FEB-88 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 3745 |
| Manufacturer | NICOLET |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-07-27 |