FDA Adverse Event
Other
Summary report: N
SYNCHROMED
MDR report key: 610541
·
Received June 1, 2005
Report
- Report Number
- 2182207-2005-00845
- Event Type
- Other
- Date Received
- June 1, 2005
- Report Date
- May 24, 2005
- Manufacturer
- NEUROLOGICAL DIVISION, MEDTRONIC, INC.
- Product Code
- LKK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE MANUFACTURER'S REPRESENTATIVE REPORTED THE PATIENT HAD BEEN EXPERIENCING A RETURN OF PAIN. THE FIRST ROLLER STUDY DIDN'T SHOW ANY MOVEMENT. A SECOND ROLLER STUDY WAS DONE THAT SHOWED THE ROLLER DID MOVE. A FOLLOW UP REPORT WILL BE SENT WHEN ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
IT WAS DETERMINED THAT THE EVENT DESCRIBED IN MANUFACTURER'S REPORT NUMBER 2182207-2005-00845 WAS PREVIOUSLY REPORTED IN MANUFACTURER'S REPORT NUMBER 6000030-2005-00970.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | PUMP | LKK | NEUROLOGICAL DIVISION, MEDTRONIC, INC. | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |