FDA Adverse Event
Injury
Summary report: N
EASYTRAK
MDR report key: 1870859
·
Received October 15, 2010
Report
- Report Number
- 2124215-2010-16935
- Event Type
- Injury
- Date Received
- October 15, 2010
- Date of Event
- August 23, 2010
- Report Date
- August 25, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- PMA / PMN Number
- P010012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME, THIS LEAD HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Additional Manufacturer Narrative · 1
OUR RECORDS INDICATE THAT THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION INDICATED THAT THIS LEAD WAS EXPLANTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD DEVELOPED AN INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYTRAK | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4538 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | MISMATCH| N119| (B)(4)| 4538| H177| 0158| (B)(4)| H217 |