FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 3911791
·
Received July 3, 2014
Report
- Report Number
- 2124215-2014-11441
- Event Type
- Injury
- Date Received
- July 3, 2014
- Date of Event
- May 7, 2014
- Report Date
- May 7, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NIK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(6). THIS LEAD HAS BEEN RETURNED. BOSTON SCIENTIFIC HAS CONCLUDED IT IS UNLIKELY THAT LEAD CHARACTERISTICS CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. 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 DISLODGED. THE LV LEAD WAS EXPLANTED AND REPLACED. AI INDICATES THAT THE LEAD WAS DISLODGED DUE TO PATIENT ANATOMY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 391830 | EASYTRAK 2 | IMPLANTABLE LEAD | NIK | CPI - DEL CARIBE | 4543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| L| R | MISMATCH| 4592| N140| 4135| 4543| 0293 |