FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 2190377
·
Received July 25, 2011
Report
- Report Number
- 6000030-2011-05745
- Event Type
- Injury
- Date Received
- July 25, 2011
- Date of Event
- January 1, 2011
- Report Date
- July 6, 2011
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CATHETER WAS UNABLE TO BE ASPIRATED. A BACK TABLE PRIME WAS GOING TO BE PERFORMED. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED, IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8627-18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J11693R27 |