FDA Adverse Event
Malfunction
Summary report: N
EASYTRAK
MDR report key: 2780586
·
Received October 10, 2012
Report
- Report Number
- 2124215-2012-12842
- Event Type
- Malfunction
- Date Received
- October 10, 2012
- Date of Event
- August 25, 2006
- Report Date
- September 14, 2012
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 LEAD WAS SCHEDULED FOR EXPLANT DURING A COMPETITIVE DEVICE REVISION PROCEDURE. THE LEAD WAS REPORTED TO BE VISIBLY FRACTURE AND TO HAVE BEEN SURGICALLY ABANDONED AND REMOVED FROM SERVICE SEVERAL YEARS PRIOR TO THE SCHEDULED EXPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE IS NO LONGER IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYTRAK | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | 4441| 4512| 1823| 1821| 0125 |