FDA Adverse Event
Injury
Summary report: N
LIVIAN
MDR report key: 1945614
·
Received January 4, 2011
Report
- Report Number
- 2124215-2010-20112
- Event Type
- Injury
- Date Received
- January 4, 2011
- Date of Event
- October 11, 2010
- Report Date
- October 11, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS OF TODAY, OUR INVESTIGATION IS COMPLETE. IF ADDITIONAL BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO A PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIVIAN | IMPLANTABLE CHF GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | H220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Life Threatening| R | 4543| 4470| 0185| H220 |