FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 2171026
·
Received June 30, 2011
Report
- Report Number
- 6000030-2011-05000
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- March 1, 2011
- Report Date
- June 9, 2011
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED ON (B)(6) 2011 THAT THE PATIENT WAS NOT GETTING THE RELIEF EXPECTED, IN CERTAIN AREAS AND A ROLLER STUDY WAS DONE WHICH INCLUDED A ROLLER STUDY BOLUS. FENTANYL AND BUPIVACAINE WERE USED IN THE PUMP. THE HCP ATTRIBUTED THE EVENT TO THE CATHETER WHICH MAY NEED TO BE REPLACED, BUT NO SURGERY HAD BEEN DONE AS OF THE TIME OF THE REPORT. THE CATHETER FAILED TO ASPIRATE. THE PUMP WAS REPROGRAMMED TO GIVE A 35UG BOLUS. THE OUTCOME WAS NO INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE REPORTED IF IT 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 | 67 YR | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8703W, LOT# L50966 |