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U.S. Department of Health and Human Services

Enforcement Report - Week of May 14, 2014

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Event Detail

Event ID 67720
Product Type Devices
Status Ongoing
Recalling Firm Medtronic Neuromodulation
City Minneapolis
State MN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-26
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide Distribution - All states in USA. OUS: List not provided at this time.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Medtronic SynchroMed® II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter. This Medical Device Correction notification affects all SynchroMed II pumps. Class II This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump. Due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk, Medtronic is not recommending prophylactic replacement of pumps. This communication is based on information available to date and was developed in collaboration with clinical experts. Medtronic continues to investigate this issue and we are committed to providing updates as more information becomes available. 195,198 pumps (146,435 US, 48,763 OUS) Z-1570-2014