FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 1951393
·
Received January 6, 2011
Report
- Report Number
- 2124215-2010-22875
- Event Type
- Injury
- Date Received
- January 6, 2011
- Date of Event
- November 23, 2010
- Report Date
- November 30, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE AND LEADS SUBSEQUENTLY WERE EXPLANTED WITH NO ADVERSE PATIENT EFFECTS.
Additional Manufacturer Narrative · 1
THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WOULD BE PART OF A SYSTEM EXPLANT 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 | Other | 0184| N119| 4554 |