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 2019-05-17 for AMPERE? RF ABLATION GENERATOR H700488 manufactured by St. Jude Medical, Inc. (af-st. Paul).
[145356391]
Based on the information provided to abbott and the investigation performed, the reported startup issue was unable to be confirmed. No hardware abnormalities that would have resulted in the reported event were identified. The returned product functioned properly during the investigation. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. The review determined the process was performed and completed in accordance with abbott specifications and procedures. The cause for the startup issue and subsequent significant procedure delay could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[145356392]
During the procedure, the generator would not boot up and a significant procedure delay occurred. The generator was able to successfully start up following an hour of troubleshooting. The patient was under anesthesia and the troubleshooting extended the total procedure time by two hours. The procedure was completed successfully with the generator. There were no adverse consequences to the patient due to the delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184149-2019-00093 |
| MDR Report Key | 8619276 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-17 |
| Date of Report | 2019-05-17 |
| Date of Event | 2019-04-11 |
| Date Mfgr Received | 2019-05-16 |
| Device Manufacturer Date | 2018-02-01 |
| Date Added to Maude | 2019-05-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CARDIAC ABLATION PERCUTANEOUS CATHETER |
| Product Code | LPB |
| Date Received | 2019-05-17 |
| Returned To Mfg | 2019-05-15 |
| Model Number | H700488 |
| Catalog Number | H700488 |
| Lot Number | 6281839 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. (AF-ST. PAUL) |
| Manufacturer Address | ONE ST. JUDE MEDICAL DRIVE ST. PAUL MN 55117 US 55117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-17 |