Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1694-2017

February 09, 2017

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 76591
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-1694-2017

Official wording

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.

Code information: Serial Number NGV526743H

Distribution pattern: IL

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.