FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3203632
·
Received July 3, 2013
Report
- Report Number
- 3004209178-2013-04786
- Event Type
- Malfunction
- Date Received
- July 3, 2013
- Date of Event
- February 1, 2011
- Report Date
- March 29, 2013
- 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
PRODUCT ID 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT PUMP RESERVOIR RESIDUAL VOLUME WAS GREATER THAN EXPECTED VOLUME AT A RESERVOIR REFILL APPOINTMENT. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCE INCREASED PAIN IN THE TWO DAYS PRIOR TO THE REFILL. THE DEVICE SYSTEM WAS USED TO DELIVER AN UNKNOWN DRUG. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 305209 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR |