FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 1192087
·
Received October 7, 2008
Report
- Report Number
- 6000030-2008-06397
- Event Type
- Injury
- Date Received
- October 7, 2008
- Report Date
- September 12, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THE PT WAS EXPERIENCING INCREASED LEG NUMBNESS. THE PT'S CATHETER WAS REVISED. THE SPINAL SEGMENT OF THE CATHETER WAS REMOVED AND A CRYSTALIZED SUBSTANCE WAS NOTED ON THE TIP. THE CATHETER WAS SENT TO PATHOLOGY (NO RESULTS REPORTED). THE PT DID HAVE LEG NUMBNESS PRIOR TO THE DEVICE SYSTEM BEING IMPLANTED. THE DRUG USED IN THE PUMP WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8627-18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED| IMPLANTED| CATHETER MODEL 8709 LOT#L55916 |