FDA Adverse Event
Other
Summary report: N
ENSITE MULTI-ELECTRODE ARRAY CATHETER
MDR report key: 1799522
·
Received August 4, 2010
Report
- Report Number
- 2184149-2010-00023
- Event Type
- Other
- Date Received
- August 4, 2010
- Date of Event
- July 6, 2010
- Report Date
- July 6, 2010
- Manufacturer
- ST. JUDE MEDICAL, AF DIVISION
- Product Code
- MTD
- PMA / PMN Number
- K983456
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
WE ARE AWAITING DEVICE RETURN. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) PCV ABLATION PROCEDURE, THE ARRAY CATHETER WAS PREPPED ACCORDING TO THE IFU, INSERTED INTO THE PT, VALIDATED, GEOMETRY CREATED THE PVC MAPPED TO THE SEPTAL RVOT. THE PT THEN COMPLAINED OF CHEST PAIN AND DEVELOPED HYPOTENSION. AN ECHOCARDIOGRAM REVEALED A SMALL EFFUSION. A PERICARDIOCENTESIS WAS DONE AND 250 CC OF BLOOD WAS REMOVED. THE PT WAS TRANSFERRED TO ICU IN STABLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENSITE MULTI-ELECTRODE ARRAY CATHETER | ARRAY CATHETER | MTD | ST. JUDE MEDICAL, AF DIVISION | EC1000 | 13520422 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other |