MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2019-11-01 for CRYOFLEX SURGICAL ABLATION PROBE 60SF2 manufactured by Medtronic, Inc..
| Report Number | 3008592544-2019-00055 |
| MDR Report Key | 9265651 |
| Report Source | STUDY |
| Date Received | 2019-11-01 |
| Date of Report | 2019-11-01 |
| Date of Event | 2019-09-10 |
| Date Mfgr Received | 2019-10-17 |
| Device Manufacturer Date | 2018-04-24 |
| Date Added to Maude | 2019-11-01 |
| 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 | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MEDTRONIC, INC. |
| Manufacturer Street | 3800 ANNAPOLIS LANE |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOFLEX SURGICAL ABLATION PROBE |
| Generic Name | SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE |
| Product Code | OCL |
| Date Received | 2019-11-01 |
| Model Number | 60SF2 |
| Catalog Number | 60SF2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 3800 ANNAPOLIS LANE MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-11-01 |