MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2012-10-31 for 0230 manufactured by Medtronic, Inc..
[2946022]
It was reported that the radio frequency ablation generator was unable to be powered on using the foot switch. The generator foot switch was returned for service. It was indicated on the return paperwork that there were no patient complications associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[10280129]
This event occurred outside the us. All information provided is included in this report. If additional relevant information is received, a supplemental report will be submitted. Patient information is not generally available due to confidentiality concerns. Evaluation summary: (b)(4) analysis confirmed the reported event. Air pressure is lost due to a hole in the tubing near the pneumatic connector.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182208-2012-04034 |
| MDR Report Key | 2811102 |
| Report Source | 01,06,07 |
| Date Received | 2012-10-31 |
| Date of Event | 2012-10-04 |
| Date Mfgr Received | 2012-10-04 |
| Date Added to Maude | 2012-12-27 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | RICHARD ROY |
| Manufacturer Street | CARDIAC RHYTHM DISEASE MGMT 8200 CORAL SEA ST. N.E. |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635262574 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ABLATION ACCESSORY |
| Product Code | ODR |
| Date Received | 2012-10-31 |
| Returned To Mfg | 2012-10-09 |
| Model Number | 0230 |
| Operator | OTHER |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | CARDIAC RHYTHM DISEASE MGMT 8200 CORAL SEA ST. N.E. MOUNDS VIEW MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-10-31 |