FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 3213096
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-10594
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- March 7, 2013
- Report Date
- June 5, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- 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 THE PATIENT WITH THIS DEVICE SYSTEM WAS PRESENTED DUE TO PERIPHERAL VASCULAR DISEASE. THE PATIENT WAS PLACED ON A VENTILATOR AND SUBSEQUENTLY BECAME (B)(6) SEPTIC. THE ENDOCARDITIS RESULTED IN THE DEVICE SYSTEM BEING EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.THE PATIENT REMAINS HOSPITALIZED DUE TO THE PERIPHERAL VASCULAR DISEASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313238 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | N119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | MISMATCH| 7121| N119 |