FDA Adverse Event
Other
Summary report: N
CONTAK RENEWAL 4 IS-1/DF-1/LV-1 - IN CLINICAL TRIAL
MDR report key: 1539930
·
Received November 10, 2009
Report
- Report Number
- 2124215-2009-21739
- Event Type
- Other
- Date Received
- November 10, 2009
- Date of Event
- August 18, 2009
- Report Date
- November 10, 2009
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL 4 IS-1/DF-1/LV-1 - IN CLINICAL TRIAL | IMPLANTABLE CHF GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | H195 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |