FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3142583
·
Received June 3, 2013
Report
- Report Number
- 6000030-2013-00131
- Event Type
- Injury
- Date Received
- June 3, 2013
- Report Date
- May 9, 2013
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8617-18, LOT# L62602, IMPLANTED: (B)(6) 1999. PRODUCT TYPE: PUMP. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD BEEN STARTED WITH BACLOFEN, BUT IT DID NOT WORK FOR HER AT ALL. IT WASN¿T UNTIL MORPHINE WAS PUT IN THE PUMP THAT SHE WAS ABLE TO ¿HAVE A LIFE AGAIN¿. SHE WAS ABLE TO SLEEP AT NIGHT AND WAS ALSO ABLE TO GET UP AND MOVE. PRIOR TO THAT, SHE HAD SPENT THE PRIOR TEN YEARS IN A BED OR HOSPITAL BECAUSE HER SPASTICITY AND PAIN COULDN¿T BE STOPPED. SHE HAD BEEN ¿IN AND OUT OF HOSPITALS CRYING¿ AND IN PAIN. IT WAS ALSO STATED THAT THE PATIENT HADN¿T BEEN ABLE TO SLEEP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 245230 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | RICE CREEK MFG | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |