FDA Adverse Event
Malfunction
Summary report: N
EASYTRAK
MDR report key: 1873806
·
Received October 19, 2010
Report
- Report Number
- 2124215-2010-17482
- Event Type
- Malfunction
- Date Received
- October 19, 2010
- Date of Event
- November 1, 2009
- Report Date
- September 1, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LEFT VENTRICULAR LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AN AMENDED REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD HAS HAD AN IMPEDANCE MEASUREMENT GREATER THAN 2000 OHMS SINCE (B)(6), 2009. THE LEAD WAS DEACTIVATED AND REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYTRAK | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4513 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other | MISMATCH| 0148| 4513| 1342T| 0085| H135| H199 |