FDA Adverse Event
Injury
Summary report: N
RELIANCE SG ACTIVE FIX SINGLE COIL 64CM
MDR report key: 1681673
·
Received May 7, 2010
Report
- Report Number
- 2124215-2010-05086
- Event Type
- Injury
- Date Received
- May 7, 2010
- Date of Event
- January 29, 2010
- Report Date
- May 7, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- LWS
- 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 | RELIANCE SG ACTIVE FIX SINGLE COIL 64CM | IMPLANTABLE LEAD | LWS | CPI - DEL CARIBE | 0181 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |