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U.S. Department of Health and Human Services

Class 2 Device Recall 8596SC: Intrathecal Catheter Pump Segment Revision Kit

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  Class 2 Device Recall 8596SC: Intrathecal Catheter Pump Segment Revision Kit see related information
Date Initiated by Firm April 14, 2008
Date Posted August 27, 2008
Recall Status1 Terminated 3 on September 10, 2008
Recall Number Z-2172-2008
Recall Event ID 48616
PMA Number P860004 
Product Classification Implanted Infusion Pump - Product Code LKK
Product Model 8596SC Intrathecal Catheter Pump Segment Revision Kit
Medtronic Inc., Minneapolis, MN 55432

A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.
Code Information All lots numbers included
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
800 53rd Ave NE
PO Box 1250
Minneapolis MN 55440-1250
For Additional Information Contact
763-514-5174
Manufacturer Reason
for Recall		 The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the continuous therapy trial period.
FDA Determined
Cause 2		 Device Design
Action Medtronic informed all Belgium implanting and managing physicians of the SynchroMed II infusion system. Each customer was mailed a Dear Healthcare Professional letter (Medtronic Urgent: Field Safety Notice) on 4/3/08 providing important safety information and patient management recommendations regarding the device incompatibility. The firm recommends that healthcare professionals do not use SC catheters if a connection with an implantable access port is required. Also, if a continuous infusion trial is required with use of an implantable access port, they should use a model 8711 intrathecal catheter. The firm states that for patients who are currently undergoing a continuous trial with an implantable port, replacing the catheter connector before connecting to the SynchroMedd II using the Medtronic model 8578 revision kit is recommended. Medtronic also recommends discussing the risks of connection failure with patients. Local field reps will personally follow-up with affected customers to confirm and document notification.
Quantity in Commerce 232 total from all models
Distribution International Distribution --- country of Belgium.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LKK and Original Applicant = MEDTRONIC Inc.
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