FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3203485
·
Received July 2, 2013
Report
- Report Number
- 3004209178-2013-03241
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- July 9, 2012
- Report Date
- July 9, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8840, LOT# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP PROGRAMMER SCREEN WENT BLANK DURING A TELEMETRY UPDATE. IT WAS DETERMINED THAT THIS WAS DUE TO LOW BATTERIES IN THE PUMP PROGRAMMER. NEW BATTERIES WERE INSERTED INTO THE PROGRAMMER AND WHEN THE PUMP WAS INTERROGATED IT WAS FOUND THAT THE PUMP WAS IN STOPPED PUMP MODE AS EXPECTED. THE PUMP WAS REPROGRAMMED AND IT WAS CONFIRMED THAT THE RE-UPDATE WAS SUCCESSFUL. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302298 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00053 YR |