FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 1950284
·
Received January 6, 2011
Report
- Report Number
- 2124215-2010-22252
- Event Type
- Injury
- Date Received
- January 6, 2011
- Date of Event
- November 12, 2010
- Report Date
- November 12, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A NEW DEVICE WILL BE IMPLANTED FOLLOWING INFECTION RESOLUTION. IF NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED DUE TO POCKET INFECTION. NO ALLEGATIONS FROM THE FIELD THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE OBSERVED CLINICAL OUTCOME. NO OTHER ADVERSE EFFECTS REPORTED THE EXPLANTED DEVICE IS NOT BEING RETURNED.
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 | 47 YR | Required Intervention | N119| 4543| 0185| 4096 |