FDA Adverse Event
Malfunction
Summary report: N
RELIANCE PASSIVE DUAL COIL IS-1/DF-1 64CM
MDR report key: 1681318
·
Received May 7, 2010
Report
- Report Number
- 2124215-2010-09145
- Event Type
- Malfunction
- Date Received
- May 7, 2010
- Date of Event
- March 29, 2010
- Report Date
- May 7, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- DTB
- 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 PASSIVE DUAL COIL IS-1/DF-1 64CM | IMPLANTABLE LEAD | DTB | CPI - DEL CARIBE | 0148 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |