FDA Adverse Event
Injury
Summary report: N
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
MDR report key: 3202898
·
Received July 2, 2013
Report
- Report Number
- 3007566237-2013-01086
- Event Type
- Injury
- Date Received
- July 2, 2013
- Report Date
- March 27, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY A PATIENT THAT THEIR HCP ¿WOULD NEVER PROGRAM A PUMP FOR FLEX BOLUS BECAUSE HE HAS HEARD OR HAD FIRSTHAND EXPERIENCE WITH PEOPLE OVERDOSING, MAYBE BECAUSE OF TAKING ADDITIONAL BREAKTHROUGH MEDS ALONG WITH THE BOLUS¿. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301385 | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |