FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3864283
·
Received June 10, 2014
Report
- Report Number
- 3004209178-2014-11320
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Report Date
- May 20, 2014
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD NOT BEEN HAPPY WITH THEIR PUMP. THE PATIENT WAS CURRENTLY ON A DILUTED BACLOFEN CONCENTRATION AND THE PUMP WAS PROGRAMMED TO MIN RATE. IT WAS STILL TOO MUCH FOR THE PATIENT AS THEIR LEGS WERE "EXCESSIVELY LOOSE." THE HEALTHCARE PROFESSIONAL (HCP) WANTED TO FILL THE PUMP WITH SALINE TODAY. IT WAS FURTHER REPORTED THEY FILLED THE PATIENTS PUMP WITH SALINE AND WERE GOING TO SEE HOW SHE DOES GETTING NO INTRATHECAL BACLOFEN FOR A FEW MONTHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 338210 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |