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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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