Reported Apr 5, 2017 · Terminated

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

Medtronic Neuromodulation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medtronic Neuromodulation · 7000 Central Ave · Minneapolis, MN · 55421-1241

Is this the product you have?

  • SynchroMed II implantable drug infusion pump, Model 8637-40,
Lot codes and dates
  • Serial Number NGV526743H
Amount recalled
1

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 4, 2018 · Data as of Sep 19, 5:27 PM UTC

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