FDA Adverse Event
Injury
Summary report: N
EASYTRAK
MDR report key: 2060122
·
Received April 15, 2011
Report
- Report Number
- 2124215-2011-05723
- Event Type
- Injury
- Date Received
- April 15, 2011
- Date of Event
- March 29, 2011
- Report Date
- March 29, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS LEAD WAS ABANDONED, THEREFORE BOSTON SCIENTIFIC CRM WILL BE UNABLE TO PERFORM ANALYSIS ON THIS LEAD. SHOULD IT BE RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD HAD DISLODGED A FEW MONTHS PRIOR TO THE DEVICE CHANGEOUT PROCEDURE. AS A RESULT, THE LEAD WAS PROGRAMMED OFF. DURING THE CHANGEOUT PROCEDURE, THE LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYTRAK | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4513 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR | Required Intervention | 4470| H175| 0185| 4513 |