FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 3043217
·
Received April 9, 2013
Report
- Report Number
- 2124215-2013-02128
- Event Type
- Injury
- Date Received
- April 9, 2013
- Date of Event
- January 21, 2013
- Report Date
- February 19, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
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 THE PATIENT WITH THIS PRODUCT WAS NOTED TO HAVE UNDERGONE NUMEROUS SURGICAL INTERVENTIONS DUE TO A POCKET INFECTION AND EROSION. IT WAS SUSPECTED THAT IN THE NEAR FUTURE A FULL SYSTEM EXPLANT WILL BE SCHEDULED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PRODUCT WAS FULLY REMOVED AND EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 146672 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | P108 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R | P108| 0175| H230| 4480| 4542| 0296 |