FDA Adverse Event
Injury
Summary report: N
ISOMED NON-PROGRAMMABLE PUMP
MDR report key: 1171214
·
Received September 22, 2008
Report
- Report Number
- 2182207-2008-05992
- Event Type
- Injury
- Date Received
- September 22, 2008
- Date of Event
- August 25, 2008
- Report Date
- August 25, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- 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
THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THE PT HAD THE PUMP REPLACED AS IT HAD BEEN UNDERINFUSING FOR "SEVERAL MONTHS". THE CONCENTRATION, DOSE, AND DRUG IN THE PUMP WERE NOT REPORTED. NO SYMPTOMS WERE REPORTED. THE PT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOMED NON-PROGRAMMABLE PUMP | LKK | MEDTRONIC NEUROMODULATION | 8472-60-10 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CATHETER MODEL CATHETER LOT# UNK| IMPLANTED| EXPLANTED |