FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 1209985
·
Received October 22, 2008
Report
- Report Number
- 2182207-2008-06778
- Event Type
- Injury
- Date Received
- October 22, 2008
- Date of Event
- January 1, 2000
- Report Date
- September 23, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RESULTS - USED FOR THE CATHETER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD A FRACTURED CATHETER AND UNDERWENT A CATHETER REVISION IN 2000. IT IS BELIEVED THAT THE OLD CATHETER TIP WAS VISIBLE, FREE-FLOATING IN THE CEREBROSPINAL FLUID, ON XRAY IN 2008. SEE MANUFACTURER'S REPORT #: 2182007-2008-06777.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8627 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PROGRAMMER MODEL 8840 LOT#UNK| IMPLANTED| EXPLANTED| CATHETER MODEL 8703W LOT#L78719 |