FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 2130500
·
Received June 14, 2011
Report
- Report Number
- 6000030-2011-04382
- Event Type
- Injury
- Date Received
- June 14, 2011
- Date of Event
- November 1, 2010
- Report Date
- May 17, 2011
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A PATIENT HAD WITHDRAWAL AND INCREASED PAIN IN (B)(6) OF 2010. THE PUMP WAS REPLACED. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A RETURN OF SYMPTOMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
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 | 55 YR | Required Intervention | LOT # NGP350068H| CATHETER: MODEL 8709, LOT # J11626R68| IMPLANTABLE INFUSION PUMP: MODEL 8637-20,| EXPLANTED| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8578, LOT # N263420005| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8835, LOT # NPG020435N| CATHETER: MODEL 8731SC, LOT # N272532016 |