Recall Z-1694-2017— Medtronic Neuromodulation
Class II · Terminated
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2017-02-09, terminated 2018-09-04. FDA's recall record names no specific 510(k) clearance for this event. Product: SynchroMed II implantable drug infusion pump, Model 8637-40,. 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
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-02-09
- Terminated
- 2018-09-04
- Firm location
- Minneapolis, MN, United States
Product description
SynchroMed II implantable drug infusion pump, Model 8637-40,
Reason for recall
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.
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