Medtronic Intellis Clinician Programmer Application Software Malfunction Prevents Parameter Adjustment
Medtronic is recalling the Intellis A710 Clinician Programmer Application version 2.0.97 because it may fail to communicate with the implanted neurostimulator, preventing clinicians from adjusting patient therapy parameters.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device recall with no reported injuries. The software defect prevents therapy parameter adjustment, posing a risk of inadequate or excessive stimulation, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
The Medtronic Intellis A710 Clinician Programmer Application, version 2.0.97 is being recalled. This software application is used by clinicians to program and adjust neurostimulation therapy for patients with implanted Medtronic neurostimulator devices.
A defect in this version of the application can prevent it from establishing a communication session with the implanted neurostimulator. When this communication failure occurs, clinicians cannot adjust the patient's stimulation parameters.
If clinicians cannot adjust stimulation parameters, patients may receive inadequate or excessive stimulation therapy and may not receive optimal pain relief. This defect was identified in a device bearing serial number NPL1000519 in Germany.
The recalled product
- Product
- Model A710 Intellis Clinician Programmer Application, version 2.0.97
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- software-defect
- parameter-control-loss
- inadequate-therapy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 00763000520076
- S/N: NPL1000519
Distribution
Distribution scope not specified by the agency.
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