FDA Adverse Event
Malfunction
Summary report: N
COGNIS
MDR report key: 3910007
·
Received July 2, 2014
Report
- Report Number
- 2124215-2014-10730
- Event Type
- Malfunction
- Date Received
- July 2, 2014
- Date of Event
- April 10, 2014
- Report Date
- April 10, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS RETURNED WITH NO REPORTED PRODUCT PERFORMANCE ISSUES AND NO REPORTED ADVERSE PATIENT EFFECTS. A REVIEW OF DEVICE MEMORY IN OUR POST MARKET QUALITY ASSURANCE LABORATORY NOTED THE DEVICE HAD RECORDED ONE SYSTEM RESET THAT WAS MOST LIKELY CAUSED BY THE USE OF ELECTROCAUTERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 388207 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | LWP | GUIDANT CRM CLONMEL IRELAND | N118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | 1388T| N118| 1297| MISMATCH| 0185| H125| 4513| 1270| N164| 4464 |