MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-03-15 for MEDTRONIC-HALL M7700 manufactured by Medtronic Inc..
[21248710]
Patient arrived in operation room as emergency on january 31, 1993 for redo mitral valve (implanted 1/6/93) replacement using a #31 prosthesis. Patient was in critical condition in icu until 2/2/93 patient was pronounced dead at 9:35 on the morningdevice labeled for single use. Patient medical status prior to event: critical 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. 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, other. Results of evaluation: none or unknown, other, inherent risk of procedure, leaflet. Conclusion: device failure directly caused event. 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 | 5408 |
| MDR Report Key | 5408 |
| Date Received | 1993-03-15 |
| Date of Report | 1993-02-09 |
| Date of Event | 1993-01-31 |
| Date Facility Aware | 1993-02-02 |
| Report Date | 1993-02-09 |
| Date Reported to Mfgr | 1993-02-09 |
| Date Added to Maude | 1993-07-12 |
| 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 | MEDTRONIC-HALL |
| Generic Name | MITRAL VALVE |
| Product Code | ISP |
| Date Received | 1993-03-15 |
| Model Number | M7700 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Age | 01-JAN-93 |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 5104 |
| Manufacturer | MEDTRONIC INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1993-03-15 |