FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 2000303
·
Received February 17, 2011
Report
- Report Number
- 6000030-2011-01181
- Event Type
- Injury
- Date Received
- February 17, 2011
- Date of Event
- March 14, 2008
- Report Date
- February 7, 2011
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DURING PUMP REPLACEMENT, IT WAS NOTED THAT IT WAS SOMEWHAT COMPLICATED. THE CATHETER WAS FRACTURED. THE CATHETER WAS REVISED AND COULD NOT BE EASILY INSERTED. THE PHYSICIAN THOUGHT THEY HAD TO DO A SMALL LAMINOTOMY. FOLLOWING THE REPLACEMENT, THE PUMP WAS FUNCTIONING WELL FOR THE PT. THE PT HAD A LOT OF THORACIC AND NECK PAINS THAT WERE BEING MANAGED BY ANOTHER PHYSICIAN. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8626L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention | IMPLANTED:| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT # J11612R37| CATHETER: MODEL 8709SC, LOT # N171980010| IMPLANTED:| LOT # NGV419697H| IMPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 8637-40,| EXPLANTED: |