FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 1944637
·
Received January 3, 2011
Report
- Report Number
- 2124215-2010-19927
- Event Type
- Injury
- Date Received
- January 3, 2011
- Date of Event
- October 7, 2010
- Report Date
- October 7, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS OF TODAY, THIS PRODUCT HAS NOT BEEN RETURNED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD HAD PREVIOUSLY HAD PERFECT POSITION FOR PACING; HOWEVER, IT WAS BELIEVED THAT THE LEAD HAD MOVED AS THE PATIENT WAS GETTING DIAPHRAGMATIC STIMULATION. THE PATIENT RECEIVED A NEW LV LEAD. NO FURTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYTRAK 2 | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention | 0185| 4592| 4543| 4470| N119 |