EASYTRAK 2
Report
- Report Number
- 2124215-2013-03828
- Event Type
- Injury
- Date Received
- April 10, 2013
- Date of Event
- February 19, 2013
- Report Date
- March 14, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS FOR THIS LEFT VENTRICULAR (LV) WAS INITIATED. ANALYSIS HAS NOT YET CONCLUDED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS AVAILABLE, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE LEAD WAS VISUALLY INSPECTED. VISUAL INSPECTION CONFIRMED THE ALLEGATION THAT THE LEAD INSULATION HAD DEGRADED. BLOOD/BODY FLUID WAS NOTED IN THE LEAD LUMEN AND AN EXTRACTION STYLET WAS RETURNED STUCK IN THE LEAD. IT APPEARED THAT ELECTRO-CAUTERY MELTED THE INSULATION AT MANY LOCATIONS ON THE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
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BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, UPON EXTRACTION FOR INFECTION, IT APPEARED THAT THE INSULATION OF THIS LEFT VENTRICULAR (LV) LEAD WAS DEGRADED. IT WAS SPECULATED THAT CAUTERY CAUSED THE DEGRADATION AND THE MELTING POINT OF POLYURETHANE WAS DISCUSSED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 152650 | EASYTRAK 2 | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization| L| R | 4087| N119| 4549| 0158| 4543 |