FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 1853552
·
Received October 5, 2010
Report
- Report Number
- 2124215-2010-14835
- Event Type
- Injury
- Date Received
- October 5, 2010
- Date of Event
- July 16, 2010
- Report Date
- July 16, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO OTHER ADVERSE PATIENT EFFECTS HAVE BEEN OBSERVED. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED DUE TO A PATIENT INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | N119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention | 4193| 6947| 7299| N119 |