FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 2081438
·
Received April 22, 2011
Report
- Report Number
- 6000030-2011-03015
- Event Type
- Malfunction
- Date Received
- April 22, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 8, 2011
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS NOT GETTING RELIEF FROM PAIN. THE ACTUAL RESIDUAL VOLUME WAS 17 ML AND THE EXPECTED RESIDUAL VOLUME IN THE PT'S PUMP WAS 5.9 ML. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE FENTANYL, BUPIVACAINE AND PRIALT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N067445| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731, LOT# N068934009 |