MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-20 for ENSITE? PRECISION? SOFTWARE H702496 manufactured by St. Jude Medical, Inc..
[176014295]
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.?
Patient Sequence No: 1, Text Type: N, H10
[176014296]
During the procedure, the anatomy of the left atrium was created. When visualizing the position pulmonary veins with the ablation catheter, the localization of the catheter within the anatomy was incorrect and appeared outside of the anatomy. The catheter was replaced with no resolution. The amplifier, tactisys, and ensite were restarted and reopened. The study was revalidated and the anatomy was recollected with the ablation catheter for the pulmonary vein ostium. The procedure was extended 45 minutes and additional anesthesia was required. The procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[188117327]
The study and collect logs were needed for the investigation but only dicom files were provided. Based on the information provided, abbott is unable to investigate the reported event. Based on the information received, the cause of the reported delay in procedure could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184149-2020-00007 |
| MDR Report Key | 9608302 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-20 |
| Date of Report | 2020-01-20 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-01-08 |
| Date Added to Maude | 2020-01-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC. |
| Manufacturer Street | ONE ST. JUDE MEDICAL DRIVE |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENSITE? PRECISION? SOFTWARE |
| Generic Name | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
| Product Code | DQK |
| Date Received | 2020-01-20 |
| Model Number | H702496 |
| Catalog Number | H702496 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Manufacturer Address | ONE ST. JUDE MEDICAL DRIVE ST. PAUL MN 55117 US 55117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-20 |