Agency classClass IOur severity:Severe FDA (Devices)·Z-1190-2013·Announced 2013-05-08

Medtronic Recalls Deep Brain Stimulation Lead Kits Due to Damage Risk

Medtronic is recalling 30,000 Deep Brain Stimulation lead kits worldwide because the provided lead cap may damage the lead connector during use.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used. The connector end…"

Plain-English summary

Medtronic Neuromodulation is recalling 30,000 units of the Medtronic DBS Lead Kit for Deep Brain Stimulation, including models 3387, 3387S, 3389, 3389S, 3391, and 3391S. The affected products are sterile and non-pyrogenic and are indicated for the treatment of Dystonia, Essential Tremor, Obsessive-Compulsive Disorder, Parkinson’s Disease, and epilepsy.

The recall is due to a potential for lead damage at the connector end when the provided lead cap is used. Medtronic has received reports that tightening or loosening the setscrew may twist the setscrew connector block, which can damage the lead. The connector end is the part of the lead that connects to the lead extension.

The affected products were distributed worldwide, including in the United States and numerous international markets. Medtronic is not removing the lead kits from the market; instead, the company is providing additional instructions for capping the lead and removing the lead cap to address the issue.

The recalled product

Product: Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system delivers electrical stimulation to selected targets in the brain. DBS Leads are indicated for…
Manufacturer: Medtronic Neuromodulation
Category: Medical Device — Neuromodulation
Hazard: device-damage
Affected units: 30,000

Distribution

Distributed nationwide across the United States.

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 →

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