MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-02 for TELECTRONICS OPTIMA - MPT 5282A manufactured by Telectronic, Inc..
[1376]
1989 pacemaker malfunctioned. Generator changeddevice labeled for single use. Patient medical status prior to event: fair 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 evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, mechanical tests performed. Results of evaluation: mechanical problem, early eol, rrt indicator - end of life, rate-modulated pacing sensing failure. Conclusion: device failure occurred and was related to event, device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2779 |
| MDR Report Key | 2779 |
| Date Received | 1993-02-02 |
| Date of Report | 1992-07-07 |
| Report Date | 1992-07-07 |
| Date Reported to FDA | 1992-07-07 |
| Date Added to Maude | 1993-03-27 |
| 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 | TELECTRONICS |
| Generic Name | TELEMETRY SERIES II |
| Product Code | GYE |
| Date Received | 1993-02-02 |
| Model Number | OPTIMA - MPT 5282A |
| Catalog Number | OPTIMA - MPT 5282A |
| Lot Number | U204594 |
| ID Number | VV1/V00 AA1/A00 |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 2605 |
| Manufacturer | TELECTRONIC, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-02-02 |