FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 1771369
·
Received July 27, 2010
Report
- Report Number
- 2124215-2010-12482
- Event Type
- Injury
- Date Received
- July 27, 2010
- Date of Event
- June 9, 2010
- Report Date
- June 9, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
A REQUEST WAS MADE FOR PRODUCT RETURN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), DEFIBRILLATION AND TRANSVENOUS LEADS WERE EXPLANTED DUE TO A PATIENT INFECTION. A NON-BOSTON SCIENTIFIC EPICARDIAL LEAD REMAINED IMPLANTED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
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 | 45 YR | Required Intervention | 4469| N119| MISMATCH| 0184 |