FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 1970126
·
Received January 14, 2011
Report
- Report Number
- 6000030-2011-00382
- Event Type
- Injury
- Date Received
- January 14, 2011
- Date of Event
- June 1, 2000
- Report Date
- January 12, 2011
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED "OUT OF ITS CATHETER CONNECTOR ANGLE" IN (B)(6) 2000; A CATHETER REVISION WAS PERFORMED. IN (B)(6) 2000, THE PT EXPERIENCED A CEREBROSPINAL FLUID LEAK WITH "BACK INFECTION". THE PT UNDERWENT "CLOSING OF CSF LEAK; CATHETER REVISION". PLEASE NOTE THAT THESE EVENTS WERE ALSO REPORTED IN MANUFACTURER'S REPORT #: 3007566237201003527.
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 | 16 YR | Required Intervention | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# L80986| EXPLANTED:| CATHETER: MODEL 8709, LOT# L70455| IMPLANTED: |