MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-13 for GOTT-DAGGETT MITRAL VALVE PROSTHESIS/STARR-EDWARDS UNKNOWN manufactured by Medtronic.
[2269]
Physical dictation " i suspect malfunction as evidenced by transient cerebrovascular episodes over the years, findings of mitral regurgitation and echocardiogram findings which have suggested thrombus formation". There was not an "event". This valve is not being used currentlydevice labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3318 |
| MDR Report Key | 3318 |
| Date Received | 1992-07-13 |
| Date of Report | 1992-01-24 |
| Date of Event | 1991-12-11 |
| Date Facility Aware | 1991-12-11 |
| Report Date | 1992-01-24 |
| Date Reported to Mfgr | 1992-01-24 |
| Date Added to Maude | 1993-04-15 |
| 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 | GOTT-DAGGETT MITRAL VALVE PROSTHESIS/STARR-EDWARDS |
| Generic Name | UNKNOWN |
| Product Code | ISP |
| Date Received | 1992-07-13 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Device Availability | N |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 3104 |
| Manufacturer | MEDTRONIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-13 |