FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 1953845
·
Received January 10, 2011
Report
- Report Number
- 2124215-2010-24013
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- December 8, 2010
- Report Date
- December 8, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
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 AN EXPLANT PROCEDURE WAS PLANNED FOR THIS DUE TO POCKET EORSION AND INFECTION. ANTIBIOTICS HAVE BEEN ADMINISTERED TO THE PATIENT UNTIL THE REPLACEMENT PROCEDURE TAKES PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | N118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention | H215| N118| 4568| 1851| 0158| 4518 |