FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1943905
·
Received December 28, 2010
Report
- Report Number
- 3004209178-2010-10809
- Event Type
- Injury
- Date Received
- December 28, 2010
- Date of Event
- December 1, 2010
- Report Date
- December 15, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
SINCE PUMP IMPLANT SURGERY, THE PT EXPERIENCED LETHARGY, SOMNOLENCE, AND WAS MORE DIFFICULT TO AWAKE. ON (B)(6) 2010, THE PT WAS IN THE ER (EMERGENCY ROOM). THE HCP (HEALTHCARE PROVIDER) CONSIDERED STOPPING THE PUMP. THE PUMP DELIVERED LIORESAL 500 MCG/ML. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention | IMPLANTED:| CATHETER: MODEL 8709SC, LOT #: N273950002| EXPLANTED: |