FDA Adverse Event
Malfunction
Summary report: N
EASYTRAK 2
MDR report key: 2170012
·
Received July 20, 2011
Report
- Report Number
- 2124215-2011-09490
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Date of Event
- May 31, 2011
- Report Date
- May 31, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS THIS LEAD WAS SURGICALLY ABANDONED, THIS CLINICAL ALLEGATION CANNOT BE CONFIRMED NOR DENIED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE REPLACEMENT PROCEDURE, INTERROGATION OF THIS LEFT VENTRICULAR LEAD REVEALED NO PACING, SENSING OR IMPEDANCE MEASUREMENTS. NO STIMULATION WAS NOTED AT MAXIMUM PACING OUTPUTS. MEASUREMENTS WITH THE PACING SYSTEM ANALYZER REVEALED THE SAME VALUES. A VISUAL INSPECTION REVEALED INSULATION DAMAGE. THE LEAD COULD NOT BE REMOVED AND WAS SURGICALLY ABANDONED. A DECISION WAS MADE TO NOT REPLACE THIS LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYTRAK 2 | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4517 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |