FDA Adverse Event
Malfunction
Summary report: N
COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L1-TE4BE1AB
MDR report key: 2001578
·
Received January 26, 2011
Report
- Report Number
- 2030404-2011-00019
- Event Type
- Malfunction
- Date Received
- January 26, 2011
- Date of Event
- December 30, 2010
- Report Date
- December 30, 2010
- Manufacturer
- ST. JUDE MEDICAL, IRVINE
- Product Code
- OAD
- PMA / PMN Number
- P060019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
WE ARE IN THE PROCESS OF EVALUATING THIS DEVICE. WHEN OUR INVESTIGATION HAS BEEN COMPLETED A FOLLOW UP REPORT WILL BE SUBMITTED. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: (B)(6) 2011. DATE THE INITIAL REPORTER PROVIDED THE INFO TO THE MANUFACTURER: (B)(6) 2010.
Description of Event or Problem · 1
IT WAS REPORTED THE FLUID LUMEN BROKE DURING THE ABLATION PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L1-TE4BE1AB | NONE | OAD | ST. JUDE MEDICAL, IRVINE | 83565 | 3194239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |