—#71729

Product

Medtronic 8578 Sutureless Pump Connector 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.

FDA product code: LKK — Pump, Infusion, Implanted, Programmable
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P860004
Affected lot / code info: All lots numbers included

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 800 53rd Ave NE PO Box 1250, Minneapolis, Minnesota 55440-1250

Distribution

Distribution pattern: International Distribution --- country of Belgium.

Timeline

Recall initiated: 2008-04-14
Posted by FDA: 2008-08-27
Terminated: 2008-09-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71729. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.