FDA Adverse Event Injury Summary report: N

INDURA

MDR report key: 1013879 · Received March 14, 2008

Report

Report Number: 6000030-2008-01269
Event Type: Injury
Date Received: March 14, 2008
Date of Event: February 15, 2008
Report Date: February 15, 2008
Manufacturer: RICE CREEK MANUFACTURING
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER

Narratives

Description of Event or Problem · 1

THE HCP REPORTED THE PATIENT PRESENTED TO THE ER WITH SYMPTOMS OF NUMBNESS AND TINGLING IN HER FEET THAT HAD STARTED THAT MORNING. THE DRUG USED IN THE PUMP IS A MIXTURE OF MORPHINE (8 MG/ML AT 5.2 MG/DAY) AND BUPIVICAINE (30 MG/ML AT 19.5 MG/DAY). THE HCP WAS CONCERNED THE PUMP WAS MALFUNCTIONING DUE TO THE SYMPTOMS BEING CONSISTENT WITH AN OVERDOSE OF BUPIVICAINE, HOWEVER, INTERROGATION SHOWED THE PUMP WAS INFUSING DRUG AS PROGRAMMED AND THE LOGS DID NOT SHOW ANYTHING ABNORMAL. THE PATIENT'S LAST REFILL WAS IN DECEMBER. THE PUMP WAS PROGRAMMED TO MINIMUM RATE. THE HCP PLANNED TO CONTINUE MEDICAL WORK-UP INCLUDING POSSIBLE PUMP AND/OR CATHETER TROUBLESHOOTING. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INDURA		LKK	RICE CREEK MANUFACTURING	8709	N074075005

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR		Required Intervention	IMPLANTABLE INFUSION PUMP MODEL 863740\| IMPLANTED:\| LOT# NGV301115H\| EXPLANTED:\| IMPLANTED:\| PROGRAMMER MODEL 8840 LOT# UNKNOWN\| EXPLANTED: