FDA Adverse Event
Injury
Summary report: N
ARCTIC FRONT CARDIAC CRYOABLATION CATHETER
MDR report key: 2250413
·
Received September 15, 2011
Report
- Report Number
- 3002648230-2011-00166
- Event Type
- Injury
- Date Received
- September 15, 2011
- Date of Event
- August 18, 2011
- Report Date
- August 19, 2011
- Manufacturer
- MEDTRONIC CRYOCATH LP
- Product Code
- OAE
- PMA / PMN Number
- P100010
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. IT WAS DISCARDED AFTER THE PROCEDURE SINCE NO MALFUNCTION OCCURRED DURING THE PROCEDURE.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
PHRENIC NERVE PALSY WAS NOTED DURING THE THAW PERIOD AFTER THE FOURTH ABLATION IN THE RIPV. THE PHRENIC NERVE WAS STILL PARALYZED AT THE END OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARCTIC FRONT CARDIAC CRYOABLATION CATHETER | OAE | MEDTRONIC CRYOCATH LP | 2AF282 | 17703 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Disability |