FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 4131738
·
Received October 1, 2014
Report
- Report Number
- 2124215-2014-14413
- Event Type
- Malfunction
- Date Received
- October 1, 2014
- Date of Event
- July 15, 2014
- Report Date
- July 15, 2014
- Manufacturer
- CPI PLANT - ST. PAUL
- Product Code
- LWP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). UPON ADDITIONAL INFORMATION THIS INVESTIGAITON WIL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD IMPEDANCES HAD INCREASED SUDDENLY OVERNIGHT AFTER BEING IMPLANTED THE DAY BEFORE. THE ELECTROGRAM APPEARED NORMAL. NO ADVERSE PATIENT EFFECTS WER REPORTED. THIS RIGHT VENTRICULAR LEAD REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 612185 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | LWP | CPI PLANT - ST. PAUL | 0685 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0685 |