FDA Adverse Event
Malfunction
Summary report: N
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
MDR report key: 3202657
·
Received July 2, 2013
Report
- Report Number
- 6000030-2013-00031
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- May 18, 2012
- Report Date
- May 18, 2012
- Manufacturer
- UNKNOWN
- Product Code
- LKK
- PMA / PMN Number
- P860004
- 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
IT WAS REPORTED THAT AN ¿08¿ ERROR CODE MESSAGE OCCURRED ON A PUMP PROGRAMMER DURING INTERROGATION OF AN IMPLANTED PUMP. THIS WAS RESOLVED BY POWER CYCLING THE PROGRAMMER. IT WAS ALSO REPORTED THAT IN THE PROCESS THE PROGRAMMER GAVE A MESSAGE THAT THE PUMP WAS STOPPED, ¿PUMP SHUT OFF FOR FIVE MINUTES¿. THIS WAS RESOLVED BY REPROGRAMMING THE PUMP. THE DRUG DELIVERED BY THE DEVICE SYSTEM WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301432 | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | UNKNOWN | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |