FDA Adverse Event
Malfunction
Summary report: N
EASYTRAK 2
MDR report key: 2161218
·
Received July 13, 2011
Report
- Report Number
- 2124215-2011-07754
- Event Type
- Malfunction
- Date Received
- July 13, 2011
- Date of Event
- April 14, 2011
- Report Date
- April 14, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
LEAD WAS REMOVED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD DISLODGED SHORTLY AFTER DEVICE IMPLANT CAUSING DIAPHRAGM STIMULATION. PHYSICIAN ELECTED NOT TO REPLACE THE LEFT VENTRICULAR (LV) LEAD DUE DIFFICULTIES ADVANCING THE LEAD THRU THE CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS 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 | 64 YR | Life Threatening| R | (B)(4)| (B)(4)| (B)(4)| (B)(4) |