FDA Adverse Event
Injury
Summary report: N
ISOMED
MDR report key: 1021094
·
Received March 27, 2008
Report
- Report Number
- 2182207-2008-01604
- Event Type
- Injury
- Date Received
- March 27, 2008
- Report Date
- May 17, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.
Description of Event or Problem · 1
LITERATURE. ROYBAL J ET AL. "PUMP REMOVAL IN INFECTED PTS WITH HEPATIC CHEMOTHERAPY PUMPS: WHEN IS IT NECESSARY?" THE AMERICAN SURGEON. OCT 2006. 72: 880-884. ONE PT EXPERIENCED BILIARY SCLEROSIS AND REQUIRED REMOVAL OF THE PUMP. PROD THOUGHT TO BE AN ISOMED PUMP, BUT THIS COULD NOT BE CONFIRMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOMED | LKK | MEDTRONIC NEUROMODULATION | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | EXPLANTED| IMPLANTED| CATHETER MODEL CATHETER LOT #UNK |