FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 1902237
·
Received November 15, 2010
Report
- Report Number
- 6000030-2010-09498
- Event Type
- Injury
- Date Received
- November 15, 2010
- Date of Event
- January 8, 2007
- Report Date
- November 8, 2010
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INTRATHECAL BACLOFEN DOSE WAS NO LONGER EFFECTIVE. THE PT EXPERIENCED INCREASED TONE RESULTING IN IN-PT HOSPITALIZATION. A CATHETER MALFUNCTION WAS SUSPECTED. THE ENTIRE CATHETER WAS REPLACED ON (B)(6) 2007 PER THE REPORT. THE EVENT WAS REPORTED TO BE MODERATELY SEVERE. THE PT'S CONDITION HAD "RESOLVED WITHOUT SEQUELAE" AS OF (B)(6) 2007.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8626 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Hospitalization| R | IMPLANTED:| CATHETER: MODEL 8711, LOT # J11471R68| IMPLANTED:| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8596, LOT # N004014103 |