FDA Adverse Event
Other
Summary report: N
SYNCHROMED II
MDR report key: 966074
·
Received June 12, 2006
Report
- Report Number
- 966074
- Event Type
- Other
- Date Received
- June 12, 2006
- Date of Event
- May 3, 2006
- Report Date
- May 16, 2006
- Manufacturer
- MEDTRONIC
- Product Code
- LKK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
IN 2006, 12:49 PM (CIG5E8) SYNCHROMED II PROGRAMMABLE PUMP FAILED. IT WAS EXPLANTED FROM PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PROGRAMMABLE PUMP | LKK | MEDTRONIC | 8637-40 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other |