MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-16 for WORKMATE? CLARIS? SYSTEM DISPLAY PLUS 100138515 H700124 manufactured by St. Jude Medical, Inc..
[186353369]
The results/method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[186353370]
During the procedure noise was experienced on the surface signals while pacing and a clinically significant delay occurred. When the physician ablated the slow pathway area for treatment of the avnrt, cs pacing at 500 ms was requested to watch for the av node conduction. With the presence of the high amplitude pacing artifact on surface egms during this case, there were large amplitude surface electrograms timed with both the pacing spike and the qrs. Rf energy was applied to the ablation catheter in the slow pathway area. During the first ablation, the av nodal conduction time was affected. The physician stopped rf ablation within 1. 2 seconds of noticing the conduction delay. Av wenckebach was tested with cs pacing and found to be 490 ms, which was 150 ms longer than had been measured at baseline. At this point the physician decided to wait for at least 30 minutes to see if the av nodal conduction time would recover to baseline measurements before deciding how to proceed. Av wenckbache was tested continually during this period at 5-10 minute intervals. After 30 minutes or more, the physician decided to administer isoproterenol. Sinus rate increased and av conduction time decreased after isoproterenol was administered. It was during this waiting time that the physician remarked that the pacing artifact on surface electrograms needed to be fixed because it was interfering with his ability to distinguish qrs complex (and therefore, monitor av conduction). Another attempt was made with rf energy. Cs pacing was performed again. The surface electrogram with the greatest amplitude artifact, lead ii, was removed from the claris live screen to eliminate its obscuring effect on the physiologic responses to pacing. The physician then chose to use focal cryo ablation in the same area until he decided to end the procedure. There was no further intervention needed. The patient was stable at the end of the procedure. The direct cause of the noise remains unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184149-2020-00028 |
| MDR Report Key | 9835157 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2016-11-29 |
| Date Added to Maude | 2020-03-16 |
| 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. (AF-ST. PAUL) |
| 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 | WORKMATE? CLARIS? SYSTEM DISPLAY PLUS |
| Generic Name | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
| Product Code | DQK |
| Date Received | 2020-03-16 |
| Model Number | 100138515 |
| Catalog Number | H700124 |
| Lot Number | 5744443 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-16 |