FDA Adverse Event
Injury
Summary report: N
ISOMED NON-PROGRAMMABLE PUMP
MDR report key: 1080193
·
Received July 22, 2008
Report
- Report Number
- 2182207-2008-04222
- Event Type
- Injury
- Date Received
- July 22, 2008
- Date of Event
- January 1, 2008
- Report Date
- June 23, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P990034
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP 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
THE PATIENT WAS REFERRED FOR OVERINFUSION SYMPTOMS (RESPIRATORY FAILURE); SHORTLY AFTERWARDS, FOLLOWED BY SYMPTOMS OF ABSENCE OF THERAPY. THE PHYSICIAN FOUND THE RESERVOIR EMPTY. THE PHYSICIAN FILLED THE PUMP WITH 10 MLS; 3 DAYS LATER, THE PHYSICIAN FOUND THE PUMP EMPTY. THE PUMP WAS EXPLANTED. THERE WAS NO PATIENT INJURY. THE PATIENT WAS "WELL". THE PUMP WAS USED TO DELIVER MORPHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOMED NON-PROGRAMMABLE PUMP | LKK | MEDTRONIC NEUROMODULATION | 8472 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Life Threatening| R |