FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 1972409
·
Received January 24, 2011
Report
- Report Number
- 6000030-2011-00551
- Event Type
- Injury
- Date Received
- January 24, 2011
- Date of Event
- January 14, 2011
- Report Date
- January 14, 2011
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED UNDERINFUSION AND A RETURN OF PAIN SYMPTOMS. X-RAYS REVEALED A CATHETER FRACTURE APPROX 10 CM FROM THE PUMP ATTACHMENT SITE. A CATHETER REVISION WAS DONE AND THE PUMP WAS ASPIRATED PRIOR TO REFILLING. THERE WERE 18 ML ASPIRATED FROM THE PUMP WHEN THE PROGRAMMER INDICATED THAT 3.5 ML SHOULD HAVE BEEN PRESENT. THE PUMP WAS REPLACED. THERE WAS NO PT INJURY AND THE PT RECOVERED WITHOUT SEQUELA. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE CLONIDINE AND XYLOCAINE.
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 | Required Intervention | EXPLANTED:| CATHETER: MODEL CATHETER, LOT# UNK| IMPLANTED: |