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Model A710 Intellis Clinician Programmer Application… recallZ-0780-2024 · Medtronic Neuromodulation · initiated Dec 19, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

OUS communication to a single German consignee will be initiated via regionally approved methods beginning 19-Dec-2023. A field service technician will go to the site and reset the INS to resolve the issue.

Recall details

Recall number
Z-0780-2024
Status
Open, Classified
Initiated by the company
Dec 19, 2023
Posted by the FDA
Jan 22, 2024
Recalling firm
Medtronic Neuromodulation
Quantity
1 tablet
Product code
LGW
FDA submissions
P840001
Distribution
Germany

Product description

Model A710 Intellis Clinician Programmer Application, version 2.0.97

Code information (models, lots, serial numbers)

UDI/DI 00763000520076, S/N: NPL1000519

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

115 devices cleared under P840001 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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