Agency classClass IIOur severity:High FDA (Devices)·Z-0125-2014·Announced 2013-11-06

Medtronic Activa Deep Brain Stimulators Recalled for Potential Overstimulation

Medtronic is recalling Activa PC and RC deep brain stimulators due to a potential for overstimulation or stimulation in the wrong area during device recovery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 recall involves a high-risk medical device with a potential for unintended brain stimulation (overstimulation), which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic Neuromodulation is recalling 38,294 units of the Activa PC (model 37601) and Activa RC (model 37612) Multi-program Rechargeable Neurostimulators for Deep Brain Stimulation. These devices are indicated for the treatment of Parkinson's disease, dystonia, and obsessive-compulsive disorder. The recall covers all serial numbers and includes units distributed worldwide, including the United States, Puerto Rico, and numerous international markets.

The recall was initiated because, under specific conditions typically related to device recovery from an over-discharge, there is a potential for overstimulation or stimulation directed to a lead electrode other than what was intended. This malfunction could result in unintended stimulation of the brain.

Patients using these devices should contact their healthcare provider or Medtronic for instructions on how to proceed. The source text does not specify a particular date for the recall or report any specific injuries or illnesses associated with this defect.

The recalled product

Product: Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. Medtronic Activa RC and Activa PC Deep Brain Stimulators are indicated for Therapy for Parkinson's Disease - Bilateral stimulation of the…
Manufacturer: Medtronic Neuromodulation
Category: Medical Device — Neurostimulator
Hazard: overstimulation
unintended-stimulation
Affected units: 38,294

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 (1)

all serial numbers

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Medtronic Neuromodulation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Medtronic Neuromodulation

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