FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 2173625
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-10752
- Event Type
- Injury
- Date Received
- July 23, 2011
- Date of Event
- June 17, 2011
- Report Date
- June 17, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
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 AFFECTED BY A PATIENT INFECTION. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR TREATMENT OF THE INFECTION AT THE INCISION SITE. THERE WAS NO REPORT OF OTHER ADVERSE PATIENT EFFECTS.
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 | 57 YR | Life Threatening | 4538| H210| 4470| 1860| 0125| N119| 4137| (B)(4)| 4554| 1782 |