SynchroMed II implantable drug infusion pump Cl II

Company: Medtronic Neuromodulation
Date of Enforcement Report 4/5/2017
Class lI:

PRODUCT

SynchroMed II implantable drug infusion pump, Model 8637-40,
Recall Number Z-1694-2017

REASON
Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II pump. The error code prevented the physician from updating the pump; however the pump was providing therapy.

RECALLING FIRM/MANUFACTURER
Medtronic Neuromodulation, Minneapolis, MN on 2/9/2017. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
1 unit

DISTRIBUTION
IL

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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