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 2017-11-28 for ENSITE? PRECISION? SOFTWARE H702496 manufactured by St. Jude Medical, Inc..
[93066896]
Related manufacturer reference: 2184149-2017-00059. During a pulmonary vein isolation procedure clinically significant delays occurred. Following radiofrequency (rf) delivery the generator displayed an error message and could no longer deliver rf. The generator was restarted to resolve the issue and resume the procedure with a delay. Later while creating the model the system froze and it was not possible to continue the procedure. The issue was resolved by restarting the dws and selecting resume procedure. The system continued to perform slowly and furthered the delay. The procedure was completed with no adverse patient consequences.
Patient Sequence No: 1, Text Type: D, B5
[108381291]
No conclusion code available. A review of the precision software files was performed. Intermittent pauses and enguide location freezing was confirmed. The cause for the reported clinically significant delay could not be determined but two factors were determined to have the potential to contribute to the performance issue experienced. First, the dws system logs showed the hard disk usage was at 93% which contributes to poor performance. Second, the study logs showed a software bug that excessively logs messages related to the reference sensor data which occurs when the data is invalid. This contributes to slow performance when disk space is low. It is recommended to remove old studies from the dws hard drive as when the hard drive is full old studies are automatically deleted and causes system slowdowns.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184149-2017-00058 |
| MDR Report Key | 7063110 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-28 |
| Date of Report | 2017-12-14 |
| Date of Event | 2017-11-03 |
| Date Mfgr Received | 2017-12-06 |
| Date Added to Maude | 2017-11-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DENISE JOHNSON |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517564470 |
| 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 | ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM |
| Product Code | DQK |
| Date Received | 2017-11-28 |
| Model Number | H702496 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Manufacturer Address | ONE ST. JUDE MEDICAL DRIVE ST. PAUL MN 55117 US 55117 |
| Brand Name | ENSITE? PRECISION? SOFTWARE |
| Generic Name | ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM |
| Product Code | JOQ |
| Date Received | 2017-11-28 |
| Model Number | H702496 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-11-28 |