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 2020-01-10 for AMPERE? RF ABLATION GENERATOR H700489 manufactured by St. Jude Medical, Inc..
[174493968]
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
[174493969]
During a procedure the generator displayed the warning messages "no catheter connected", "contact st. Jude medical", and "high impedance". The generator was power cycled and all cables were changed but the issue remained. The patient was already in the procedure room when the case was cancelled. There were no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
[188741290]
This model number is not commercially available in the u. S. ; however, it is similar to a device sold in the u. S. The product code and pma number listed, is the information for the similar comparator device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184149-2020-00001 |
| MDR Report Key | 9574805 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-10 |
| Date of Report | 2020-03-06 |
| Date of Event | 2019-11-28 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2015-02-18 |
| Date Added to Maude | 2020-01-10 |
| 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 | AMPERE? RF ABLATION GENERATOR |
| Generic Name | GENERATOR, LESION, RADIOFREQUENCY |
| Product Code | GXD |
| Date Received | 2020-01-10 |
| Returned To Mfg | 2020-03-02 |
| Model Number | H700489 |
| Lot Number | 4983893 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-01-10 |