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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