FDA Adverse Event Injury Summary report: N

INDURA

MDR report key: 884793 · Received July 24, 2007

Report

Report Number: 2182207-2007-02297
Event Type: Injury
Date Received: July 24, 2007
Report Date: January 10, 2007
Manufacturer: NEUROLOGICAL DIVISION, MEDTRONIC INC.
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

Description of Event or Problem · 1

MCMILLIAN, MD, ET AL. "CATHETER-ASSOCIATED MASSES IN PATIENTS RECEIVING INTRATHECAL ANALGESIC THERAPY." INTL ANESTHESIA RESEARCH SOCIETY. 2003; 96: 186-90. THE PATIENT WITH FAILED BACK SURGERY SYNDROME DEVELOPED A CATHETER ASSOCIATED MASS AND WAS ASYMPTOMATIC. THE MEDICATION WAS MORPHINE 25 MG/ML AT A DAILY DOSE OF 3.5 MG AND 0.25% BUPIVICAINE. THE DURATION OF THERAPY WAS 16 MONTHS. THE PATIENT HAD PREVIOUSLY BEEN TREATED WITH A SPINAL CORD STIMULATOR THAT HAD BECOME INEFFECTIVE AND LEFT IN PLACE BEFORE THE START OF INTRATHECAL THERAPY. SHE WAS COMPLETELY ASYMPTOMATIC AND RECEIVING EXCELLENT ANALGESIA AT THE TIME OF THE DIAGNOSIS OF THE MASS. SHE ELECTED TO CONTINUE INTRATHECAL THERAPY WITH A DIFFERENT OPIOD AND WAS TREATED WITH A CONTINUOUS INFUSION OF HYDROMORPHONE IN BUPIVACAINE WITHOUT ANY INTERRUPTION OF THERAPY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INDURA		LKK	NEUROLOGICAL DIVISION, MEDTRONIC INC.	CATHETER	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	47 YR		Required Intervention	PROGRAMMER MODEL PROGRAMMER LOT# UNKNOWN\| IMPLANTED:\| EXPLANTED:\| IMPLANTED:\| IMPLANTABLE INFUSION PUMP MODEL PUMP LOT# UNKNOWN\| EXPLANTED: