FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3121483
·
Received May 21, 2013
Report
- Report Number
- 3004209178-2013-07953
- Event Type
- Malfunction
- Date Received
- May 21, 2013
- Report Date
- April 26, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
THE PATIENT REPORTEDLY HAD A FLOW STUDY DONE ¿TWO¿ (B)(6) AGO. THE MEDICATION WAS SHOWN AS FLOWING INTO THE INTRATHECAL SPACE BUT ¿WAS ALSO LEAKING OUT AT OTHER PLACES BUT THEY SAID THEY WOULDN¿T DO ANYTHING ABOUT IT¿. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM AT THE TIME OF THIS REPORTED EVENT WAS NOT REPORTED AND NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224393 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00044 YR |