FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 1061190
·
Received June 16, 2008
Report
- Report Number
- 6000030-2008-03269
- Event Type
- Injury
- Date Received
- June 16, 2008
- Date of Event
- May 1, 2008
- Report Date
- May 19, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT PRESENTED TO THE HCP WITH WORSENING SPASMS AND WAS ADMITTED TO THE HOSPITAL. THE HCP CHECKED THE PT WITH AN X-RAY AND FOUND BREAKAGE OF HIS CATHETER. CT SCAN AND CATHETER ACCESS PORT STUDY WERE ALSO SCHEDULED. THE PT WAS SCHEDULED FOR CATHETER REPLACEMENT IN 2008. THE PUMP WILL BE REPLACED AT THE SAME TIME DUE TO PENDING END OF LIFE. THE PUMP CONTAINED GABALON - CONCENTRATION AND DAILY DOSE NOT REPORTED. THE PT WAS ADMINISTERED BACLOFEN UNTIL THE SURGERY WAS PERFORMED.
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 | 50 YR | Hospitalization| R | PROGRAMMER MODEL #: UNK| SERIAL #: UNK| EXPLANTED:| IMPLANTED:| CATHETER MODEL #: 8711 LOT #: J11145R15 |