FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 3243632
·
Received July 23, 2013
Report
- Report Number
- 2124215-2013-11813
- Event Type
- Injury
- Date Received
- July 23, 2013
- Date of Event
- June 26, 2013
- Report Date
- July 25, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.
Additional Manufacturer Narrative · 1
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THE LEAD WAS RETURNED SEVERED 91 MILLIMETERS (MM) FROM THE TERMINAL PIN. VISUAL INSPECTIONS OF THE ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATION.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD DISLODGED. AN INVASIVE PROCEDURE WAS PERFORMED. THIS LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 344022 | EASYTRAK 2 | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| L| R | 4555| N140| 0293| 4543| 4470| 4195 |