FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 1970152
·
Received January 14, 2011
Report
- Report Number
- 6000030-2011-00405
- Event Type
- Injury
- Date Received
- January 14, 2011
- Date of Event
- October 1, 2007
- Report Date
- January 11, 2011
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT WAS TREATED WITH A BACLOFEN PUMP FOR CERVICAL DYSTONIA THAT LASTED AND WORKED WELL FOR SEVEN AND HALF YRS. IT WAS REPLACED ONLY WHEN THE CATHETER BECAME DISCONNECTED FROM THE PUMP. THE MEDICATION IN THE PUMP WAS LIORESAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention | CATHETER: MODEL 8709, LOT# L78004| IMPLANTED:| EXPLANTED: |