Percept PC Implantable Neurostimulator May Become Unresponsive During Cardioversion
The Model B35200 Percept PC Neurostimulator may become unresponsive during cardioversion procedures when circuit electronics are damaged. Affected patients should contact their healthcare provider.
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: The device presents a risk of malfunction during a critical cardiac procedure (cardioversion), classified as FDA Class II. No hospitalizations or illnesses have been reported. The conditional nature of the hazard and absence of reported incidents support a High rather than Severe rating.
Plain-English summary
Medtronic Neuromodulation has issued a recall of the Model B35200 Percept PC BrainSense Implantable Neurostimulator. This device is implanted to treat neurological conditions. The recall affects approximately 10,006 units distributed worldwide, including the United States and Puerto Rico.
During cardioversion procedures—when a cardiologist corrects an abnormal heartbeat—the device may become unresponsive and non-functional. Cardioversion can damage the circuit electronics within the Percept PC stimulator, causing device failure.
Patients with implanted Model B35200 devices are potentially affected, particularly those who may require or undergo cardioversion. The affected serial numbers are listed in the recall details provided by the FDA.
Patients with this device should contact their healthcare provider or Medtronic Neuromodulation immediately to discuss their individual risk and any necessary follow-up care or device management options.
The recalled product
- Product
- Model B35200 - Percept PC BrainSense Implantable Neurostimulator
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 10,006
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 (20)
- GTIN 00763000253363
- Serial Numbers: NPI714835H
- NPI714811H
- NPI714812H
- NPI714814H
- NPI714816H
- NPI714817H
- NPI714819H
- NPI714820H
- NPI714750H
- NPI714764H
- NPI714771H
- NPI714794H
- NPI714682H
- NPI714709H
- NPI714710H
- NPI714594H
- NPI714598H
- NPI714599H
- NPI714602H
Distribution
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