FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 1871908
·
Received October 16, 2010
Report
- Report Number
- 2124215-2010-17431
- Event Type
- Injury
- Date Received
- October 16, 2010
- Date of Event
- August 26, 2010
- Report Date
- August 26, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD HAD DISLODGED AND EXHIBITED HIGH THRESHOLDS. A REPOSITION WAS ATTEMPTED BUT THE SUPERIOR VENA CAVA VEIN WAS FOUND TO BE OCCLUDED. DURING EXTRACTION OF THE LEAD, IT WAS SEVERED BY THE EXTRACTION TOOL. TO DATE, THERE HAVE BEEN 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 | 4517 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | 4469| N118| 4517| 0184| H215 |