FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1842006
·
Received September 21, 2010
Report
- Report Number
- 3004209178-2010-07153
- Event Type
- Injury
- Date Received
- September 21, 2010
- Date of Event
- January 1, 2010
- Report Date
- August 16, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT NEVER EXPERIENCED THERAPEUTIC EFFECT. NO TROUBLESHOOTING WAS PERFORMED. THE PATIENT'S CATHETER WAS INITIALLY PLACED EPIDURALLY. A REVISION SURGERY OCCURRED TO REMOVE THE OLD CATHETER AND PLACE A NEW CATHETER IN THE INTRATHECAL (IT) SPACE. THE MEDICATION USED IN THE PATIENT'S PUMP WAS LIORESAL AT A CONCENTRATION OF 2,000 MCG/ML AND A DOSAGE OF 515 MCG/DAY. THE LIORESAL CONCENTRATION WAS TO BE DECREASED TO 500 MCG/ML WITH NO NEW DOSAGE PROVIDED. THE PATIENT WAS NOTED TO BE "DOING WELL". NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
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 | 25 YR | Required Intervention | IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N195499006| EXPLANTED: |