FDA Adverse Event
Injury
Summary report: N
INFUSION PUMP, UNKNOWN
MDR report key: 3910653
·
Received July 2, 2014
Report
- Report Number
- 3007566237-2014-01860
- Event Type
- Injury
- Date Received
- July 2, 2014
- Report Date
- June 11, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE HEALTHCARE PROFESSIONAL (HCP) HAD A PATIENT, WITH A PAIN PUMP, WHO "STOOPED DOWN IN A STORE TO PICK SOMETHING UP AND BECAME PARALYZED". THE MEDICATION IN THE PUMP WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 386333 | INFUSION PUMP, UNKNOWN | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |