FDA Adverse Event
Malfunction
Summary report: N
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
MDR report key: 3201643
·
Received July 2, 2013
Report
- Report Number
- 3007566237-2013-00948
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Report Date
- March 1, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
COMPANY REPRESENTATIVE REPORTED PATIENT WAS INCARCERATED TWO YEARS AGO AND THE PUMP HAS BEEN ALARMING FOR EMPTY RESERVOIR CONDITION. IT WAS REPORTED PUMP WAS IMPLANTED IN 2010 AND AFTER THE FIRST REFILL PATIENT WAS INCARCERATED AND HAVE NEVER BEEN REFILLED SINCE. IT WAS REPORTED THE PATIENT WAS REFUSED TO BE SEEN BY THE PHYSICIAN¿S GROUP. PATIENT¿S AND PUMP SYSTEM¿S INFORMATION WAS UNKNOWN AT THE TIME OF THIS REPORT. PAIN WAS REPORTED AS SYMPTOM. CAUSE OF THE PUMP ALARM REPORTED AS EMPTY PUMP. PATIENT OUTCOME UNKNOWN. MEDICATION IN THE PUMP UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A REPORT WILL BE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301651 | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |