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