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 2020-02-20 for DISPOSABLE SIMPLICITY ELECTRODE RFDE-SI RFDE-SIRFDE-SI manufactured by St. Jude Medical, Inc..
[180184405]
Investigation results will be provided in the final report. Further information regarding the event were requested but not received.
Patient Sequence No: 1, Text Type: N, H10
[180184406]
During a procedure, two of the three thermocouple modules on the simplicity probe were detached during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182269-2020-00019 |
| MDR Report Key | 9733334 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-20 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2018-11-19 |
| Date Added to Maude | 2020-02-20 |
| 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. (AF-MINNETONKA) |
| Manufacturer Street | 14901 DEVEAU PLACE |
| Manufacturer City | MINNETONKA MN 55345 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55345 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE SIMPLICITY ELECTRODE |
| Generic Name | PROBE, RADIOFREQUENCY LESION |
| Product Code | GXI |
| Date Received | 2020-02-20 |
| Model Number | RFDE-SI |
| Catalog Number | RFDE-SIRFDE-SI |
| Lot Number | 6737143 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 14901 DEVEAU PLACE MINNETONKA MN 55345 US 55345 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-20 |