FDA Adverse Event
Malfunction
Summary report: N
EASYTRAK 2 LVA DUAL ELECTRODE IS-1 PASSIVE 90CM
MDR report key: 1683672
·
Received May 7, 2010
Report
- Report Number
- 2124215-2010-06933
- Event Type
- Malfunction
- Date Received
- May 7, 2010
- Date of Event
- March 18, 2010
- Report Date
- May 7, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- LWP
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYTRAK 2 LVA DUAL ELECTRODE IS-1 PASSIVE 90CM | IMPLANTABLE LEAD | LWP | CPI - DEL CARIBE | 4543 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |