Medtronic SynchroMed II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II

FDA device recall Z-1570-2014 · posted 2014-05-08 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

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 re

Action taken

Medtronic sent a "Urgent Medical Device Correction" letter dated March 2014. The letter was sent to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter provided the Explanation of the Issue, Scope and Severity, Recommendations, and Important Guidelines. Customer visits were started by Medtronic field Representatives on February 26th, 2014. Medtronic is communicating this information to the appropriate regulatory agencies globally, including the U.S. Food and Drug Administration. We are committed to continuing to improve our product performance and services to enable you to manage your patients in a safe and effective manner. If you have questions, please contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am- 6pm CST.

Root cause

Under Investigation by firm

Status

Terminated

Product code

LKK

Quantity affected

195,198 pumps (146,435 US, 48,763 OUS)

Distribution

Worldwide Distribution - All states in USA. OUS: List not provided at this time.

Date initiated

2014-02-26

Date posted

2014-05-08

Date terminated

2018-09-28

Location

Minneapolis, MN