FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 3050018
·
Received April 10, 2013
Report
- Report Number
- 2124215-2013-05076
- Event Type
- Injury
- Date Received
- April 10, 2013
- Date of Event
- February 19, 2013
- Report Date
- February 19, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE AVAILABLE FOR RETURN. 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 DURING A ROUTINE DEVICE OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS WERE OBSERVED. THE PHYSICIAN DECIDED TO CHANGE OUT THE DEVICE AND LEAD AS THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE LEFT VENTRICULAR (LV) LEAD WAS CAPPED AND REPLACED WITH A COMPETITIVE LEAD. THERE WERE NO ADVERSE PATIENT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 151922 | EASYTRAK 2 | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Life Threatening| R | H215| 1290| N161| 0185| MISMATCH| 4518 |