FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 3043131
·
Received April 9, 2013
Report
- Report Number
- 2124215-2013-01519
- Event Type
- Injury
- Date Received
- April 9, 2013
- Date of Event
- January 14, 2013
- Report Date
- March 8, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.
Additional Manufacturer Narrative · 1
UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATION REVEALED NO LEAD FRACTURE. RESISTANCE TESTING WAS PERFORMED REVEALING NORMAL LEAD MEASUREMENTS. ANALYSIS CONCLUDED THIS LEAD MET SPECIFICATION.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS LEFT VENTRICULAR LEAD DISPLAYED A HIGH OUT OF RANGE IMPEDANCE MEASUREMENT AND WAS NOT PACING. LEAD FRACTURE WAS SUSPECTED. A REVISION WAS PERFORMED. THIS LEAD WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145793 | EASYTRAK 2 | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4542 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |