FDA Adverse Event
Injury
Summary report: N
FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE
MDR report key: 3851912
·
Received June 5, 2014
Report
- Report Number
- 3002648230-2014-00090
- Event Type
- Injury
- Date Received
- June 5, 2014
- Date of Event
- March 21, 2014
- Report Date
- May 12, 2014
- Manufacturer
- MEDTRONIC CRYOCATH LP
- Product Code
- LPB
- PMA / PMN Number
- P020045
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION; IT WAS DISCARDED AFTER THE PROCEDURE. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
CRYOABLATION PROCEDURE PERFORMED (B)(6) 2014. INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT A PATIENT WAS DIAGNOSED WITH PULMONARY EMBOLISM ON (B)(6) 2014. PATIENT REPORTED PAIN IN THE SHOULDER BLADE. PATIENT HOSPITALIZED AND TREATED WITH XARELTO. ECG AND BLOOD TESTS PERFORMED AND WERE NORMAL FOR THE PATIENT. EVENT RESOLVED ON (B)(6) 2014 AND PATIENT DISCHARGED FROM HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329186 | FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE | CARDIAC ABLATION PERCUTANEOUS CATHETER | LPB | MEDTRONIC CRYOCATH LP | 227F3 | 42090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00061 YR | Hospitalization |