MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-12-02 for MYOCARDIAL LEAD 4320 N/A manufactured by Possis Medical, Inc..
[1074]
Cpi received information that the patient experienced spontaneous asymptomatic shocks. A diagnostic test, beep-a-gram, found intermittent double counting. The other device was another sensing leadinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding 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. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
[1783]
Second paragraph:invasive procedure found an insulation break in one of the rate sensing leads. The physician repaired the lead and the acid functioned appropriately. The leads remain implantedinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding 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. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-1992-00003 |
| MDR Report Key | 1892 |
| Date Received | 1992-12-02 |
| Date of Report | 1992-11-17 |
| Date of Event | 1992-11-10 |
| Date Facility Aware | 1992-11-16 |
| Report Date | 1992-11-17 |
| Date Reported to FDA | 1992-11-17 |
| Date Reported to Mfgr | 1992-11-17 |
| Date Added to Maude | 1992-12-14 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MYOCARDIAL LEAD |
| Generic Name | SENSING LEAD |
| Product Code | DRW |
| Date Received | 1992-12-02 |
| Model Number | 4320 |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | FIRM CONTROL # 33788 |
| Device Availability | * |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 1767 |
| Manufacturer | POSSIS MEDICAL, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-12-02 |