Fw: FDA Alert: Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal Catheters, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit

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FDA Alert: Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal

Catheters, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump

Segment Revision Kit

FDA Alert: Medtronic Neuromodulation INDURA One-Piece (IP)

Intrathecal Catheters, Sutureless Pump Connector Revision Kit, and Intrathecal

Catheter Pump Segment Revision Kit

Medtronic and FDA notified healthcare professionals of the

Class I Recall of several Medtronic intrathecal catheters and intrathecal

catheter revision kits used with the implanted Medtronic SyncroMed II,

SynchroMed EL, and IsoMed infusion pumps that store and deliver parenteral drugs

to the intrathecal space. The products were recalled because of potential

misconnections of the Medtronic Sutureless Connector Catheters from the catheter

port on the pump. These misconnections have resulted in a blockage between the

sutureless pump connector and the catheter port on the pump and disconnection

from the pump connector.

Product: Medtronic Neuromodulation INDURA IP:

a.. Intrathecal Catheter, Model 8709SC I

b.. ntrathecal Catheter, Model 8731SC

c.. Sutureless Pump; Connector Revision Kit, Model 8678

d.. Intrathecal Catheter Pump Segment Revision Kit, Model

8596SC

These products were manufactured beginning on November 21,

2006 and are still being manufactured, and were distributed beginning in January

22, 2007 and are still in distribution.

This recall does not include the Medtronic MiniMed infusion

pumps.

The intrathecal catheter or intrathecal catheter revision kits

use a sutureless connector for the final connection to the implanted Medtronic

SyncroMed II, SynchroMed EL, and IsoMed infusion pumps. The catheter is part of

an infusion system that stores and delivers parenteral drugs to the intrathecal

space.

Recalling Firm: Medtronic Neuromodulation, 800 53rd Avenue NE,

Minneapolis, Minnesota 55440-1250

Reason for Recall: This recall is being conducted due to

potential misconnections of the Medtronic sutureless connector ( " SC " ) catheters

from the catheter port on the pump. These misconnections have resulted in a

blockage (occlusion) between the sutureless pump connector and the catheter port

on the pump and disconnection from the pump connector.

Public Contact: Patients with questions are encouraged to talk

with their physician or contact Medtronic Patient Services at 1-800-510-6735,

Monday - Friday, 8 a.m. to 5 p.m. Central Daylight Time.

Physicians with medical questions related to this issue or

Medtronic therapies should contact Medtronic at 1-800-328-0810, Monday - Friday,

8 a.m. to 5 p.m. Central Daylight Time.

FDA Comment: In June 2008, the company sent a notification to

healthcare professionals which described the problem. The notification

identified the:

a.. affected catheters

b.. revision kits' model numbers

c.. associated implantable infusion pumps

The notification recommended that healthcare professionals:

a.. verify cerebrospinal fluid (csf) backflow through the

catheter

b.. ensure alignment of sutureless connector to the pump

c.. snap the sutureless connector into place

d.. tug and rotate to test the connection

e.. follow recommendations for managing patients with

implanted " SC " catheters

f.. provide ongoing education of patients and caregivers of

the signs and symptoms of drug underdose and withdrawal

Class 1 recalls are the most serious type of recall and

involve situations in which there is a reasonable probability that use of the

product will cause serious injury or death.

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