FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 2032471
·
Received March 25, 2011
Report
- Report Number
- 6000030-2011-02309
- Event Type
- Injury
- Date Received
- March 25, 2011
- Date of Event
- January 1, 2007
- Report Date
- March 11, 2011
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S PUMP HAD BEEN EXPLANTED DUE TO A MALFUNCTION APPROXIMATELY 4 YEARS AGO. SWELLING HAD OCCURRED AROUND THE PUMP SITE AND THE PT VISITED AN ER, WHERE IT WAS DETERMINED THAT THE PUMP HAD "BUSTED" AND FLUID HAD ESCAPED OUT AROUND THE PUMP. IT WAS SEVERAL DAYS LATER THAT THE PUMP WAS EXPLANTED DUE TO IT LEAKING. THE PT'S CATHETER WAS ALSO EXPLANTED ALONG WITH THE PUMP. THE PT WAS NOTED AS BEING IN TERRIBLE SHAPE PRIOR TO EXPLANT, BUT FOLLOWING THE REMOVAL OF THE IMPLANTED DEVICES, THE PT'S STATUS IS GOOD. ADD'L INFO 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 | EXPLANTED:| CATHETER: MODEL 8709, LOT# L75130| IMPLANTED: |