FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1936133
·
Received December 13, 2010
Report
- Report Number
- 3004209178-2010-10370
- Event Type
- Injury
- Date Received
- December 13, 2010
- Date of Event
- January 1, 2010
- Report Date
- November 18, 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
DESPITE INCREASING DOSES OF MEDICATION, THE PT'S SPASTICITY DID NOT IMPROVE. THE PUMP DELIVERED LIORESAL. PER THE REPORTER, THE PT DID NOT EXPERIENCE WITHDRAWAL SYMPTOMS SINCE THE PT DID NOT USE ORAL BACLOFEN. THE MANAGING HCP (HEALTHCARE PROVIDER) INSISTED THE CATHETER BE REPLACED. THE SURGEON DID NOT BELIEVE ANYTHING WAS WRONG WITH THE CATHETER WHEN IT WAS REPLACED.
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 | 12 YR | Other | IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N147419008| EXPLANTED: |