FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 3213551
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-07598
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- April 29, 2013
- Report Date
- April 29, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- Reporter Occupation
- PHYSICIAN
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 LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO LEAD INSERTION DIFFICULTY. ADDITIONAL INFORMATION WAS OBTAINED FROM FIELD REPRESENTATIVE REVEALED THE LV LEAD HAD PULLED BACK AND WAS NOT RETURNED AS IT WAS DROPPED IN SHARP BOX. THE LV LEAD IS NO LONGER IN SERVICE AND REPLACED WITH A COMPETITOR'S LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313709 | EASYTRAK 2 | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4542 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| L| R | 4542| N140| MISMATCH| 4076| 4548 |