FDA Adverse Event
Malfunction
Summary report: N
DISCOVERY SR
MDR report key: 1041520
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-32021
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- October 7, 2005
- Report Date
- January 10, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DXY
- Removal / Correction Number
- Z1032-39/5
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- NURSE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISCOVERY SR | IMPLANTABLE PULSE GENERATOR | DXY | CARDIAC PACEMAKERS, INC | 1174 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other |