FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 2905456
·
Received January 9, 2013
Report
- Report Number
- 2124215-2012-15341
- Event Type
- Injury
- Date Received
- January 9, 2013
- Date of Event
- October 1, 2012
- Report Date
- October 1, 2012
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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 THIS PRODUCT WAS PART OF A SYSTEM THAT WILL UNDERGO A REVISION IN THE NEAR FUTURE DUE TO AN INFECTION. NO ACTION OTHER THAN LIKELY INTRAVENOUS INTERVENTION HAS BEEN TAKEN AT THIS TIME. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10592 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | P107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R | P107| 4554| 4592| 4473| 0158 |