MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-01 for C10 0020 manufactured by Cardiac Pacemakers, Inc. (division Of Eli Lily).
[21606218]
Patient with aicd expired on 5/29/93. Device removed and interrogated. Results indicate that device fired thirteen (13) times. Lead impedence of last firing measured greater than 250 ohms. Review of chest x-ray of 5/1/92 shows small area of radiolucency at the subclavian, first rib junctiondevice 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 evaluated after the event. Method of evaluation: electrical tests performed. Results of evaluation: component failure. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: maybe. Corrective actions: other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5776 |
| MDR Report Key | 5776 |
| Date Received | 1993-07-01 |
| Date of Report | 1993-06-08 |
| Date of Event | 1993-05-29 |
| Date Facility Aware | 1993-05-29 |
| Report Date | 1993-06-08 |
| Date Reported to FDA | 1993-06-08 |
| Date Reported to Mfgr | 1993-06-08 |
| Date Added to Maude | 1993-07-27 |
| 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 |
| Generic Name | SUPERIOR VENA CAVA LEAD |
| Product Code | LWT |
| Date Received | 1993-07-01 |
| Model Number | C10 |
| Catalog Number | 0020 |
| Lot Number | UNKNOWN |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 01-SEP-88 |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 5475 |
| Manufacturer | CARDIAC PACEMAKERS, INC. (DIVISION OF ELI LILY) |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1993-07-01 |