FDA-Device2017-04-05Class II

SynchroMed II implantable drug infusion pump, Model 8637-40,

Medtronic Neuromodulation
Hazard

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.

Sold states
IL
Affected count
1
Manufactured in
7000 Central Ave, Minneapolis, MN, United States
Products
SynchroMed II implantable drug infusion pump, Model 8637-40,

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1694-2017

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