Model A710 Intellis Clinician Programmer Application, version 2.0.97
Summary
The FDA issued a Class II for Model A710 Intellis Clinician Programmer Application, version 2.0.97 by Medtronic Neuromodulation. Reason: Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the.
Details
Source
Device Recall
External ID
Z-0780-2024
Action Date
2024-01-31
Status
Ongoing
Category
device
Product Description
Model A710 Intellis Clinician Programmer Application, version 2.0.97
Lot/Code Info: UDI/DI 00763000520076, S/N: NPL1000519
Quantity Affected: 1 tablet
Reason for Recall
Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.
Distribution
Germany
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-19
Company
Minneapolis, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 144 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Neuromodulation has 50 FDA actions in our database, including 49 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Neuromodulation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Neuromodulation have FDA actions?
Medtronic Neuromodulation has 50 FDA actions in our database, including 49 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0780-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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