FDA Adverse Event
Malfunction
Summary report: N
NEUROMODULATION PUMP, UNKNOWN
MDR report key: 3202167
·
Received July 2, 2013
Report
- Report Number
- 3007566237-2013-00175
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Report Date
- April 11, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP HAD BEEN DRY FOR ABOUT ONE OR TWO WEEKS. A PUMP REFILL WAS DONE. PATIENT HAD BEEN SEEN BY THE HEALTH CARE PROFESSIONAL SINCE THE REFILL AND WAS NOTED ¿DOING FINE.¿ THE DRUG DELIVERED VIA THE PUMP WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301090 | NEUROMODULATION PUMP, UNKNOWN | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |